K001460 is an FDA 510(k) clearance for the VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by bioMerieux, Inc. (Rockland, US). The FDA issued a Cleared decision on October 4, 2000, 147 days after receiving the submission on May 10, 2000.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K001460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2000 |
| Decision Date | October 04, 2000 |
| Days to Decision | 147 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 |