K161139 is an FDA 510(k) clearance for the LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on July 22, 2016, 91 days after receiving the submission on April 22, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K161139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2016 |
| Decision Date | July 22, 2016 |
| Days to Decision | 91 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 |