The following data is part of a premarket notification filed by Enteric Products, Inc. with the FDA for The Aptus (automated) Application Of The Hm-cap Eia Kit. An Enzyme Linked Immunosorbent Assay For The Detection Of The S.
| Device ID | K984544 |
| 510k Number | K984544 |
| Device Name: | THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S |
| 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 | 1998-12-22 |
| Decision Date | 1999-02-18 |