FDA Product Code
FDA Product Code LON — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.1645
510(k) Clearances — 291 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260283 | VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) | bioMerieux, Inc. | 2026-10-01 | Traditional | PDF ↗ |
| K260619 | VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) | Biomérieux, Inc. | 2026-09-28 | Traditional | PDF ↗ |
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | 2026-04-15 | Traditional | PDF ↗ |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | BIOMERIEUX | 2026-03-26 | Traditional | PDF ↗ |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | bioMerieux, Inc. | 2025-08-21 | Traditional | PDF ↗ |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | Becton, Dickinson and Company | 2025-08-08 | Traditional | PDF ↗ |
| K250447 | BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | Becton, Dickinson and Company | 2025-05-19 | Traditional | PDF ↗ |
| K234012 | VITEK COMPACT PRO | bioMerieux, Inc. | 2025-03-14 | Traditional | PDF ↗ |
| K250344 | BD Phoenix Automated Microbiology System | Becton, Dickinson and Company | 2025-03-06 | Special | PDF ↗ |
| K233986 | BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL) | Becton, Dickinson and Company | 2024-03-15 | Traditional | PDF ↗ |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | bioMerieux, Inc. | 2024-03-11 | Traditional | PDF ↗ |
| K232756 | Colibrí | Copan Wasp Srl | 2023-12-27 | Traditional | PDF ↗ |
| K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | bioMerieux, Inc. | 2023-10-23 | Traditional | PDF ↗ |
| K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin | bioMerieux, Inc. | 2023-07-05 | Traditional | PDF ↗ |
| K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | bioMerieux, Inc. | 2023-06-26 | Traditional | PDF ↗ |
| K211748 | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | 2023-04-19 | Traditional | PDF ↗ |
| K222430 | VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin | Biomerieux Sa, Inc. | 2023-03-09 | Traditional | PDF ↗ |
| K223478 | VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin | bioMerieux, Inc. | 2023-02-16 | Traditional | PDF ↗ |
| K222073 | VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) | bioMerieux, Inc. | 2023-02-09 | Traditional | PDF ↗ |
| K223481 | VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) | bioMerieux, Inc. | 2023-02-03 | Traditional | PDF ↗ |
| K220803 | VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin | bioMerieux, Inc. | 2023-01-27 | Traditional | PDF ↗ |
| K211759 | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | 2023-01-18 | Traditional | PDF ↗ |
| K220805 | VITEK 2 AST-Gram Positive Cefoxitin Screen | bioMerieux, Inc. | 2022-10-13 | Traditional | PDF ↗ |
| K220546 | Colibrí System | Copan Wasp Srl | 2022-10-05 | Traditional | PDF ↗ |
| K212243 | VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) | bioMerieux, Inc. | 2022-08-08 | Traditional | PDF ↗ |
| K213899 | VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin | bioMerieux, Inc. | 2022-07-12 | Traditional | PDF ↗ |
| K213931 | VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) | bioMerieux, Inc. | 2022-06-03 | Traditional | PDF ↗ |
| K214023 | VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) | bioMerieux, Inc. | 2022-04-14 | Traditional | PDF ↗ |
| K213241 | VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole | bioMerieux, Inc. | 2022-02-25 | Traditional | PDF ↗ |
| K212849 | VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL) | Biomérieux, Inc. | 2022-02-04 | Special | PDF ↗ |
| K210287 | VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) | bioMerieux, Inc. | 2021-10-28 | Traditional | PDF ↗ |
| K202396 | VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) | bioMerieux, Inc. | 2021-09-14 | Traditional | PDF ↗ |
| K211630 | VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) | bioMerieux, Inc. | 2021-08-30 | Traditional | PDF ↗ |
| K201675 | VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) | bioMerieux, Inc. | 2021-07-09 | Traditional | PDF ↗ |
| K211136 | VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) | bioMerieux, Inc. | 2021-06-14 | Traditional | PDF ↗ |
| K193299 | VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) | bioMerieux, Inc. | 2020-09-28 | Traditional | PDF ↗ |
| K201405 | LabPro Data Management System | Beckman Coulter, Inc. | 2020-08-30 | Traditional | PDF ↗ |
| K200590 | VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) | bioMerieux, Inc. | 2020-04-28 | Traditional | PDF ↗ |
| K193572 | VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) | bioMerieux, Inc. | 2020-03-13 | Traditional | PDF ↗ |
| K193567 | VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 >=16 ug/mL) | bioMerieux, Inc. | 2020-02-14 | Traditional | PDF ↗ |
| K192110 | Vitek Densichek | bioMerieux, Inc. | 2019-10-31 | Traditional | PDF ↗ |
| K191766 | VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) | bioMerieux, Inc. | 2019-08-05 | Traditional | PDF ↗ |
| K190905 | BD Phoenix Automated Microbiology System GN Ceftaroline (0.0156-4 µg/mL) | Becton, Dickinson and Company | 2019-07-01 | Traditional | PDF ↗ |
| K190616 | VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL) | bioMerieux, Inc. | 2019-06-06 | Traditional | PDF ↗ |
| K183524 | VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) | bioMerieux, Inc. | 2019-03-12 | Traditional | PDF ↗ |
| K183551 | VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) | bioMerieux, Inc. | 2019-03-07 | Traditional | PDF ↗ |
| K183360 | VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL) | bioMerieux, Inc. | 2019-02-26 | Traditional | PDF ↗ |
| K183415 | VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) | bioMerieux, Inc. | 2019-02-20 | Traditional | PDF ↗ |
| K181766 | VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance | bioMerieux, Inc. | 2018-12-10 | Traditional | PDF ↗ |
| K181665 | BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN | Becton, Dickinson and Company | 2018-09-21 | Traditional | PDF ↗ |
| K173523 | BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) | Becton, Dickinson and Company | 2018-02-09 | Traditional | PDF ↗ |
| K173252 | BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) | Becton, Dickinson and Company | 2018-01-05 | Traditional | PDF ↗ |
| K172944 | VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL | bioMerieux, Inc. | 2017-12-19 | Traditional | PDF ↗ |
| K172731 | VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) | bioMerieux, Inc. | 2017-12-08 | Traditional | PDF ↗ |
| K162737 | VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL) | bioMerieux, Inc. | 2017-06-21 | Traditional | PDF ↗ |
| K163637 | BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) | Becton Dickinson & Company | 2017-03-21 | Traditional | PDF ↗ |
| K163563 | VITEK 2 AST-GN Gentamicin (<=1 >=16 µg/mL) | bioMerieux, Inc. | 2017-03-13 | Traditional | PDF ↗ |
| K161437 | VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) | bioMerieux, Inc. | 2017-02-16 | Traditional | PDF ↗ |
| K161510 | VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) | bioMerieux, Inc. | 2017-02-13 | Traditional | PDF ↗ |
| K163083 | VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL) | bioMerieux, Inc. | 2017-02-01 | Traditional | PDF ↗ |
| K163006 | VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) | bioMerieux, Inc. | 2017-01-24 | Traditional | PDF ↗ |
| K161217 | VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) | bioMerieux, Inc. | 2017-01-12 | Traditional | PDF ↗ |
| K161227 | VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) | bioMerieux, Inc. | 2016-07-20 | Traditional | PDF ↗ |
| K152075 | VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) | bioMerieux, Inc. | 2016-04-15 | Traditional | PDF ↗ |
| K151320 | BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml | Becton, Dickinson and Company | 2016-01-15 | Traditional | PDF ↗ |
| K142170 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP | Becton, Dickinson and Company | 2014-10-28 | Traditional | PDF ↗ |
| K141149 | VITEK 2 AST GP CEFTAROLINE | bioMerieux, Inc. | 2014-06-20 | Traditional | PDF ↗ |
| K140468 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML) | Becton, Dickinson and Company | 2014-06-02 | Traditional | PDF ↗ |
| K132909 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML) | Becton, Dickinson and Company | 2014-02-14 | Traditional | PDF ↗ |
| K132674 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) | Becton, Dickinson and Company | 2013-12-27 | Traditional | PDF ↗ |
| K132507 | VITEK 2 AST ST MEROPENEM | bioMerieux, Inc. | 2013-11-15 | Traditional | PDF ↗ |
| K131779 | VITEK 2 AST-ST TIGECYCLINE | bioMerieux, Inc. | 2013-10-10 | Traditional | PDF ↗ |
| K132573 | VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN | bioMerieux, Inc. | 2013-09-13 | Traditional | PDF ↗ |
| K131331 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML) | Becton, Dickinson & CO | 2013-07-10 | Traditional | PDF ↗ |
| K123404 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) | Becton, Dickinson & CO | 2013-06-27 | Traditional | PDF ↗ |
| K123266 | BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN | Becton, Dickinson and Company | 2013-06-26 | Traditional | PDF ↗ |
| K121546 | VITEK 2 GRAM NEGATIVE DOXYCYCLINE | bioMerieux, Inc. | 2012-11-20 | Traditional | PDF ↗ |
| K121100 | VITEK 2 AST STREPTOCOCUS VANCOMYCIN | bioMerieux, Inc. | 2012-11-19 | Traditional | PDF ↗ |
| K122547 | GRAM POSTITVE CLINDAMYCIN | bioMerieux, Inc. | 2012-10-15 | Traditional | PDF ↗ |
| K122359 | VITEK 2 STRPTOCOCCUS CEFTRIAXONE | bioMerieux, Inc. | 2012-08-28 | Traditional | PDF ↗ |
| K121863 | VITEK 2 AST-ST CEFOTAXIME | bioMerieux, Inc. | 2012-08-16 | Traditional | PDF ↗ |
| K113783 | VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE | bioMerieux, Inc. | 2012-08-07 | Traditional | PDF ↗ |
| K113200 | VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM | bioMerieux, Inc. | 2012-06-29 | Traditional | PDF ↗ |
| K111893 | VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE | bioMerieux, Inc. | 2012-02-28 | Traditional | PDF ↗ |
| K111976 | VITEK 2 STREPTOCOCCUS ERYTHROMYCIN | bioMerieux, Inc. | 2012-02-17 | Traditional | PDF ↗ |
| K113305 | VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE | bioMerieux, Inc. | 2012-02-10 | Traditional | PDF ↗ |
| K110106 | VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE | bioMerieux, Inc. | 2011-11-30 | Traditional | PDF ↗ |
| K112000 | VITEK 2 STREPTOCOCCUS PENICILLIN | bioMerieux, Inc. | 2011-10-26 | Traditional | PDF ↗ |
| K111909 | VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE | bioMerieux, Inc. | 2011-10-18 | Traditional | PDF ↗ |
| K103752 | VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE | bioMerieux, Inc. | 2011-10-14 | Traditional | PDF ↗ |
| K112228 | VITEK 2 STREPTOCOCCUS LEVOFLOXACIN | bioMerieux, Inc. | 2011-10-03 | Traditional | PDF ↗ |
| K112129 | VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN | bioMerieux, Inc. | 2011-09-27 | Traditional | PDF ↗ |
| K112075 | VITEK 2 STRPTOCOCCUS AMPICILLIN | bioMerieux, Inc. | 2011-09-15 | Traditional | PDF ↗ |
| K111599 | VITEK 2 AST-ST LINEZOLID | bioMerieux, Inc. | 2011-08-12 | Traditional | PDF ↗ |
| K093076 | VITEK 2 GRAM POSITIVE DOXCYCLINE | bioMerieux, Inc. | 2010-10-21 | Traditional | PDF ↗ |
| K093224 | DENSICHECK PLUS | bioMerieux, Inc. | 2009-11-09 | Special | PDF ↗ |
| K092919 | MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 | Siemens Healthcare Diagnostics | 2009-10-23 | Special | PDF ↗ |
| K083536 | DENSICHEK PLUS | bioMerieux, Inc. | 2009-09-11 | Traditional | PDF ↗ |
| K091899 | VITEK 2 GRAM NEGATIVE MEROPENEM | bioMerieux, Inc. | 2009-08-14 | Traditional | PDF ↗ |
| K091126 | VITEK 2 GRAM POSITIVE DAPTOMYCIN | bioMerieux, Inc. | 2009-06-18 | Traditional | PDF ↗ |
Product code LON · Class II · Microbiology. Data: openFDA.