K915185 is an FDA 510(k) clearance for the GAP IGG H.PYLORI MODIFIED. 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 March 4, 1992, 107 days after receiving the submission on November 18, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K915185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1991 |
| Decision Date | March 04, 1992 |
| Days to Decision | 107 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 |