LQP
12 FDA 510(k) clearances · Product code
75 daysmedian time to decision
204 days90th percentile
12clearances measured
FDA profile
- Official device name
- Campylobacter Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3110
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Curian Campy (K210976) | Meridian Bioscience, Inc. | 2021-12-23 |
| Sofia 2 Campylobacter FIA (K211342) | Quidel Corporation | 2021-11-23 |
| Campylobacter Chek (K191442) | Techlab, Inc. | 2019-06-20 |
| Campylobacter Quik Chek (K191456) | Techlab, Inc. | 2019-06-20 |
| CAMPYLOBACTER CHEK (K173219) | Techlab, Inc. | 2018-01-22 |
| CAMPYLOBACTER QUIK CHEK (K173217) | Techlab, Inc. | 2018-01-22 |
| IMMUNOCARD STAT CAMPY, MODEL 751530 (K090700) | Meridian Bioscience, Inc. | 2009-05-28 |
| PREMIER CAMPY, MODEL 618096 (K083464) | Meridian Bioscience, Inc. | 2009-01-30 |
| PROSPECT CAMPYLOBACTER MICROPLATE ASSAY (K982315) | Alexon - Trend, Inc. | 1998-11-18 |
| MERITEC(TM)-CAMPY (JCL) (K880389) | Meridian Diagnostics, Inc. | 1988-04-12 |
| BBL CAMPYSLIDE(TM) TEST (K864027) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-12-11 |
| COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI (K862814) | Institute Virion , Ltd. | 1986-09-30 |
Track LQP automatically
Every clearance here is in the API, with alerts when new ones post.