K181400 is an FDA 510(k) clearance for the H. PYLORI CHEK™. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on August 21, 2018, 84 days after receiving the submission on May 29, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K181400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2018 |
| Decision Date | August 21, 2018 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LYR - Helicobacter Pylori |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |