The following data is part of a premarket notification filed by Biomerica, Inc. with the FDA for Gap Igg H.pylori Modified.
| Device ID | K915185 |
| 510k Number | K915185 |
| Device Name: | GAP IGG H.PYLORI MODIFIED |
| 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 | 1991-11-18 |
| Decision Date | 1992-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00083059070040 | K915185 | 000 |
| 08305900070040 | K915185 | 000 |