The following data is part of a premarket notification filed by Enteric Products, Inc. with the FDA for Pp-cap Eia For The Detection Of Iga Antibodies To H. Pylori.
| Device ID | K001177 |
| 510k Number | K001177 |
| Device Name: | PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI |
| Classification | Helicobacter Pylori |
| Applicant | ENTERIC PRODUCTS, INC. 25 EAST LOOP DR. Stony Brook, NY 11790 |
| Contact | Jeffrey Peacock |
| Correspondent | Jeffrey Peacock ENTERIC PRODUCTS, INC. 25 EAST LOOP DR. Stony Brook, NY 11790 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-11 |
| Decision Date | 2000-11-13 |