The following data is part of a premarket notification filed by Schiff & Co. with the FDA for Hm-cap Eia Test (modification).
| Device ID | K955085 |
| 510k Number | K955085 |
| Device Name: | HM-CAP EIA TEST (MODIFICATION) |
| Classification | Helicobacter Pylori |
| Applicant | SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-26 |
| Decision Date | 1996-02-09 |