K900343 is an FDA 510(k) clearance for the GAP-IGG. This device is classified as a Helicobacter Pylori (Class I - General Controls, product code LYR).
Submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on August 22, 1991, 576 days after receiving the submission on January 23, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K900343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1990 |
| Decision Date | August 22, 1991 |
| Days to Decision | 576 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | LYR - Helicobacter Pylori |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |