The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Anti-tissue Transglutaminase (ttg)antibody Test.
| Device ID | K992878 |
| 510k Number | K992878 |
| Device Name: | ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 |
| Contact | Kevin Lawson |
| Correspondent | Kevin Lawson IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-26 |
| Decision Date | 1999-10-15 |