The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Iga Anti-gliadin (iga-aga) Antibody Test Kit.
| Device ID | K964341 |
| 510k Number | K964341 |
| Device Name: | IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT |
| Classification | Antibodies, Gliadin |
| Applicant | IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Contact | Richard E Greco |
| Correspondent | Richard E Greco IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-31 |
| Decision Date | 1997-05-30 |