LQP — Campylobacter Spp. Class I
FDA Device Classification
Classification Details
- Product Code
- LQP
- Device Class
- Class I
- Regulation Number
- 866.3110
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K210976 | meridian bioscience | Curian Campy | December 23, 2021 |
| K211342 | quidel corporation | Sofia 2 Campylobacter FIA | November 23, 2021 |
| K191456 | techlab | Campylobacter Quik Chek | June 20, 2019 |
| K191442 | techlab | Campylobacter Chek | June 20, 2019 |
| K173219 | techlab | CAMPYLOBACTER CHEK | January 22, 2018 |
| K173217 | techlab | CAMPYLOBACTER QUIK CHEK | January 22, 2018 |
| K090700 | meridian bioscience | IMMUNOCARD STAT CAMPY, MODEL 751530 | May 28, 2009 |
| K083464 | meridian bioscience | PREMIER CAMPY, MODEL 618096 | January 30, 2009 |
| K982315 | alexon - trend | PROSPECT CAMPYLOBACTER MICROPLATE ASSAY | November 18, 1998 |
| K880389 | meridian diagnostics | MERITEC(TM)-CAMPY (JCL) | April 12, 1988 |
| K864027 | bd becton dickinson vacutainer systems preanalytic | BBL CAMPYSLIDE(TM) TEST | December 11, 1986 |
| K862814 | institute virion | COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI | September 30, 1986 |