K141133 is an FDA 510(k) clearance for the VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by BIOMERIEUX (Hazelwood, US). The FDA issued a Cleared decision on July 9, 2015, 434 days after receiving the submission on May 1, 2014.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K141133 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2014 |
| Decision Date | July 09, 2015 |
| Days to Decision | 434 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 |