The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immulisa Enhanced Celiac Fusion (ttg/dgp) Iga/igg Antibody Elisa.
| Device ID | K123713 |
| 510k Number | K123713 |
| Device Name: | IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 -2120 |
| Contact | Kevin J Lawson |
| Correspondent | Kevin J Lawson IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 -2120 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-04 |
| Decision Date | 2013-10-25 |