K173219 is an FDA 510(k) clearance for the CAMPYLOBACTER 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 January 22, 2018, 111 days after receiving the submission on October 3, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K173219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2017 |
| Decision Date | January 22, 2018 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LQP - Campylobacter Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |