The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Eia For Detection Of Antibodies H. Pylori.
| Device ID | K905409 |
| 510k Number | K905409 |
| Device Name: | EIA FOR DETECTION OF ANTIBODIES H. PYLORI |
| Classification | Helicobacter Pylori |
| Applicant | E-Z-EM, INC. 583 MOUNTAIN AVE. North Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff E-Z-EM, INC. 583 MOUNTAIN AVE. North 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 | 1990-12-03 |
| Decision Date | 1991-06-10 |