Campylobacter Chek
FDA 510(k) clearance K191442 · decided 2019-06-20
Clearance details
- K-number
- K191442
- Device name
- Campylobacter Chek
- Applicant
- Techlab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-30
- Decision date
- 2019-06-20
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- LQP
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Blacksburg, VA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Curian Campy (K210976) | Meridian Bioscience, Inc. | 2021-12-23 |
| Sofia 2 Campylobacter FIA (K211342) | Quidel Corporation | 2021-11-23 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.