K191456 is an FDA 510(k) clearance for the Campylobacter Quik Chek. This device is classified as a Campylobacter Spp. (Class I - General Controls, product code LQP).
Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on June 20, 2019, 20 days after receiving the submission on May 31, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K191456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2019 |
| Decision Date | June 20, 2019 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LQP - Campylobacter Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |