FDA Product Code
FDA Product Code JTN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.1620
510(k) Clearances — 331 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K000130 | HARDYDISK, NALIDIXIC ACID, 30MCG | Hardy Diagnostics | 2000-02-29 | Traditional | PDF ↗ |
| K000183 | HARDYDISK, PIPERACILLIN, 100MCG | Hardy Diagnostics | 2000-02-28 | Traditional | PDF ↗ |
| K000128 | HARDYDISK, CEFAZOLIN, 30MCG | Hardy Diagnostics | 2000-02-18 | Traditional | PDF ↗ |
| K000022 | HARDYDISK CEFAMANDOLE, 30MCG | Hardy Diagnostics | 2000-02-17 | Traditional | PDF ↗ |
| K994134 | HARDYDISK OXACILLIN, 1MCG | Hardy Diagnostics | 2000-02-17 | Traditional | PDF ↗ |
| K994135 | HARDYDISK ERYTHROMYCIN, 15MCG | Hardy Diagnostics | 2000-02-16 | Traditional | PDF ↗ |
| K994150 | HARDYDISK NORFLOXACIN, 10MCG | Hardy Diagnostics | 2000-02-16 | Traditional | PDF ↗ |
| K994212 | HARDYDISK MEZLOCILLIN 75MCG | Hardy Diagnostics | 2000-02-15 | Traditional | PDF ↗ |
| K994091 | HARDYDISK GENTAMICIN, 10MCG | Hardy Diagnostics | 2000-02-11 | Traditional | PDF ↗ |
| K994129 | HARDYDISK CEFIXIME, 5MCG | Hardy Diagnostics | 2000-02-11 | Traditional | PDF ↗ |
| K994089 | HARDYDISK CHLORAMPHENICOL, 30MCG | Hardy Diagnostics | 2000-02-11 | Traditional | PDF ↗ |
| K994046 | HARDYDISK CEFACLOR 30MCG | Hardy Diagnostics | 2000-02-01 | Traditional | PDF ↗ |
| K994132 | HARDYDISK IMIPENEM, 10MCG | Hardy Diagnostics | 2000-01-18 | Traditional | PDF ↗ |
| K994067 | HARDY DISK AMPICILLIN/SULBACTAM | Hardy Diagnostics | 2000-01-14 | Traditional | PDF ↗ |
| K994063 | HARDYDISK AZTREONAM, 30MCG | Hardy Diagnostics | 2000-01-14 | Traditional | PDF ↗ |
| K994051 | HARDYDISK DOXYCYCLINE, 30MCG | Hardy Diagnostics | 2000-01-10 | Traditional | PDF ↗ |
| K993993 | HARDYDISK AMIKACIN 30MCG | Hardy Diagnostics | 1999-12-27 | Traditional | PDF ↗ |
| K993994 | HARDYDISK AZITHROMYCIN 15MCG | Hardy Diagnostics | 1999-12-21 | Traditional | PDF ↗ |
| K993577 | CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC | Becton Dickinson Microbiology Systems | 1999-12-01 | Traditional | PDF ↗ |
| K992853 | PASCO MIC AND MIC/ID PANELS, CEFDINIR | Pasco Laboratories, Inc. | 1999-11-04 | Traditional | PDF ↗ |
| K993186 | SYNERCID, 15 UG, BBL SENSI-DISC | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1999-11-03 | Traditional | PDF ↗ |
| K992726 | PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS ORGANISMS | Pasco Laboratories, Inc. | 1999-11-03 | Traditional | PDF ↗ |
| K992717 | PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN | Pasco Laboratories, Inc. | 1999-11-02 | Traditional | PDF ↗ |
| K992646 | PASCO MIC AND MIC/ID PANELS, PENICILLIN | Pasco Laboratories, Inc. | 1999-10-19 | Traditional | PDF ↗ |
| K992647 | PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN | Pasco Laboratories, Inc. | 1999-10-19 | Traditional | PDF ↗ |
| K992593 | PASCO MIC AND MIC/ID PANELS, CHLORAMPHENICOL | Pasco Laboratories, Inc. | 1999-10-14 | Traditional | PDF ↗ |
| K992568 | PASCO MIC AND MIC/ID PANELS, CEFOTAXIME | Pasco Laboratories, Inc. | 1999-10-14 | Traditional | PDF ↗ |
| K992562 | PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE | Pasco Laboratories, Inc. | 1999-10-13 | Traditional | PDF ↗ |
| K992546 | PASCO MIC AND MIC/ID PANELS, MEROPENEM | Pasco Laboratories, Inc. | 1999-10-12 | Traditional | PDF ↗ |
| K992507 | PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN | Pasco Laboratories, Inc. | 1999-10-08 | Traditional | PDF ↗ |
| K992420 | MODIFICATION OF PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 1999-09-27 | Traditional | PDF ↗ |
| K992297 | PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN | Pasco Laboratories, Inc. | 1999-09-03 | Traditional | PDF ↗ |
| K992077 | PASCO MIC AND MIC/ID PANELS (OFLOXACIN) | Pasco Laboratories, Inc. | 1999-09-03 | Traditional | PDF ↗ |
| K992076 | PASCO MIC AND MIC/ID PANELS (CEFUROXIME) | Pasco Laboratories, Inc. | 1999-08-30 | Traditional | PDF ↗ |
| K984513 | TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1999-04-02 | Traditional | PDF ↗ |
| K984608 | GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1999-03-09 | Traditional | PDF ↗ |
| K984036 | NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1999-01-13 | Traditional | PDF ↗ |
| K983718 | MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1998-12-11 | Traditional | PDF ↗ |
| K982520 | CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1998-09-09 | Traditional | PDF ↗ |
| K982526 | SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1998-09-09 | Traditional | PDF ↗ |
| K982517 | CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1998-09-09 | Traditional | PDF ↗ |
| K982528 | NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1998-09-09 | Traditional | PDF ↗ |
| K982669 | OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1998-09-09 | Traditional | PDF ↗ |
| K982524 | AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1998-09-09 | Traditional | PDF ↗ |
| K982519 | LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1998-09-09 | Traditional | PDF ↗ |
| K982523 | SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1998-09-09 | Traditional | PDF ↗ |
| K982235 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 1998-07-30 | Traditional | PDF ↗ |
| K981517 | CEFDINIR, 5 UG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1998-06-09 | Traditional | PDF ↗ |
| K980955 | PASCO MIC AND MIC/ID PANELS | Pasco Laboratories, Inc. | 1998-05-18 | Traditional | PDF ↗ |
| K980683 | TROVAFLOXACIN 10G, SENSI-DISC | Becton Dickinson Microbiology Systems | 1998-05-01 | Traditional | PDF ↗ |
| K974578 | GREPAFLOXACIN, 5 MG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1998-02-23 | Traditional | PDF ↗ |
| K971636 | RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1998-01-28 | Traditional | PDF ↗ |
| K974394 | ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1998-01-14 | Traditional | PDF ↗ |
| K971637 | COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1997-12-23 | Traditional | PDF ↗ |
| K973479 | CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1997-12-01 | Traditional | PDF ↗ |
| K973488 | LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1997-10-10 | Traditional | PDF ↗ |
| K973489 | LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1997-10-10 | Traditional | PDF ↗ |
| K973487 | CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1997-10-06 | Traditional | PDF ↗ |
| K971638 | CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1997-08-20 | Traditional | PDF ↗ |
| K971632 | TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1997-08-13 | Traditional | PDF ↗ |
| K972098 | FOSFOMYCIN, 200 MG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1997-07-28 | Traditional | PDF ↗ |
| K971633 | PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1997-07-03 | Traditional | PDF ↗ |
| K971631 | CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1997-07-03 | Traditional | PDF ↗ |
| K971635 | AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Oxoid , Ltd. | 1997-07-03 | Traditional | PDF ↗ |
| K971120 | DISPENS-O-DISC (TM) LEVOFLOXACIN | Difco Laboratories, Inc. | 1997-04-14 | Traditional | PDF ↗ |
| K971211 | DISPENS-O-DISC SPARFLOXACIN | Difco Laboratories, Inc. | 1997-04-14 | Traditional | PDF ↗ |
| K970831 | REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK | Remel, Inc. | 1997-04-02 | Traditional | PDF ↗ |
| K970830 | REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK | Remel, Inc. | 1997-04-02 | Traditional | PDF ↗ |
| K970385 | SPARFLOZACIN, 5 MCG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1997-03-10 | Traditional | PDF ↗ |
| K970212 | LEVOFLOXACIN, 5MCG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1997-03-06 | Traditional | PDF ↗ |
| K964491 | NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-07 | Traditional | PDF ↗ |
| K964487 | IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-07 | Traditional | PDF ↗ |
| K964492 | CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-07 | Traditional | PDF ↗ |
| K964490 | AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-07 | Traditional | PDF ↗ |
| K964489 | CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-07 | Traditional | PDF ↗ |
| K964495 | CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-07 | Traditional | PDF ↗ |
| K964501 | SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-06 | Traditional | PDF ↗ |
| K964493 | OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-06 | Traditional | PDF ↗ |
| K964512 | CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-06 | Traditional | PDF ↗ |
| K964496 | CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC | Unipath , Ltd. | 1997-02-06 | Traditional | PDF ↗ |
| K965159 | CETIBUTEN, 30MCG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1997-02-04 | Traditional | PDF ↗ |
| K964421 | REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK | Remel, L.P. | 1996-12-06 | Traditional | PDF ↗ |
| K963845 | MEROPENEM, 10 MCG, SENSI-DISC | Becton Dickinson Microbiology Systems | 1996-10-25 | Traditional | PDF ↗ |
| K963508 | DISPENS-O-DISC MEROPENEM | Difco Laboratories, Inc. | 1996-09-26 | Traditional | PDF ↗ |
| K961819 | STREPTOMYCIN DISK (300MCG) | Remel, L.P. | 1996-07-10 | Traditional | PDF ↗ |
| K961818 | GENTAMICIN DISK (120MCG) | Remel, L.P. | 1996-07-10 | Traditional | PDF ↗ |
| K961188 | CEFEPIME, 30 MCG, SENSI-DISC | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1996-04-05 | Traditional | PDF ↗ |
| K955669 | REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK | Remel Co. | 1996-02-23 | Traditional | PDF ↗ |
| K944275 | DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. | Difco Laboratories, Inc. | 1994-12-19 | Traditional | PDF ↗ |
| K943407 | GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS | Becton Dickinson Microbiology Systems | 1994-10-27 | Traditional | PDF ↗ |
| K935975 | REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG | Remel, Inc. | 1994-09-19 | Traditional | PDF ↗ |
| K940359 | PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC | Becton Dickinson Microbiology Systems | 1994-03-01 | Traditional | PDF ↗ |
| K930702 | DRYSLIDE CEFIN | Difco Laboratories, Inc. | 1993-12-22 | Traditional | PDF ↗ |
| K934100 | REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK | Remel Co. | 1993-11-22 | Traditional | PDF ↗ |
| K933657 | REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK | Remel Co. | 1993-10-28 | Traditional | PDF ↗ |
| K933118 | REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK | Remel Co. | 1993-08-10 | Traditional | PDF ↗ |
| K932052 | ADAMS SCIENTIFIC SENSITIVITY DISCS | Adams Scientific, Inc. | 1993-07-19 | Traditional | PDF ↗ |
| K931799 | REMEL LORACARBEF 30 MCG SUSCEPTIBILITY DISK | Remel Co. | 1993-06-15 | Traditional | PDF ↗ |
| K931289 | REMEL CEFPODOXIME 10 MCG SUSCEPTIBILITY DISK | Remel Co. | 1993-06-02 | Traditional | PDF ↗ |
| K931290 | REMEL CEFMETAZOLE 30 MCG SUSCEPTIBILITY DISK | Remel Co. | 1993-05-20 | Traditional | PDF ↗ |
Product code JTN · Class II · Microbiology. Data: openFDA.