FDA Product Code
FDA Product Code OOI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2570
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243922 | Revogene | Meridian Bioscience, Inc. | 2025-03-20 | Traditional | PDF ↗ |
| K222779 | Revogene | Meridian Bioscience, Inc. | 2023-01-26 | Special | PDF ↗ |
| K220480 | Revogene | Meridian Bioscience, Inc. | 2022-07-11 | Traditional | PDF ↗ |
| K170558 | revogene | Genepoc, Inc. | 2017-05-25 | Traditional | PDF ↗ |
| K161495 | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) | Luminex Corporation | 2016-06-30 | Special | PDF ↗ |
| K160517 | ARIES System | Luminex Corporation | 2016-04-12 | Special | PDF ↗ |
| K151917 | ARIES System | Luminex Corporation | 2015-10-06 | Traditional | PDF ↗ |
| K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A | Alere Scarborough, Inc. | 2015-07-16 | Special | PDF ↗ |
| K140447 | BD VIPER LT SYSTEM | Becton, Dickinson and Company | 2014-05-20 | Traditional | PDF ↗ |
| K123955 | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT | Life Technologies Corporation | 2013-03-08 | Traditional | PDF ↗ |
| K113319 | ROTOR-GENE Q MDX | QIAGEN GmbH | 2012-02-06 | Traditional | PDF ↗ |
| K102314 | 3M INTEGRATED CYCLER (110V) & (220V) | Focus Diagnostics, Inc. | 2010-10-29 | Traditional | PDF ↗ |
| K093383 | NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG | bioMerieux, Inc. | 2010-07-06 | Traditional | PDF ↗ |
| K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 | Abbott Molecular, Inc. | 2010-05-28 | Traditional | PDF ↗ |
Product code OOI · Class II · Clinical Chemistry. Data: openFDA.