The following data is part of a premarket notification filed by Biomerica, Inc. with the FDA for Gap-igg.
| Device ID | K900343 |
| 510k Number | K900343 |
| Device Name: | GAP-IGG |
| Classification | Helicobacter Pylori |
| Applicant | BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Contact | Perry G Rucker |
| Correspondent | Perry G Rucker BIOMERICA, INC. 1533 MONROVIA AVE. Newport Beach, CA 92663 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-23 |
| Decision Date | 1991-08-22 |