The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Anti-human Tissue Transglutaminase (hu-ttg) Antibody Total Iga/igg Elisa.
| Device ID | K040095 |
| 510k Number | K040095 |
| Device Name: | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 |
| Contact | Kevin J Lawson |
| Correspondent | Kevin J 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 | 2004-01-20 |
| Decision Date | 2004-03-05 |