The following data is part of a premarket notification filed by Scimedx Corp. with the FDA for Eu-ttg Iga Elisa.
| Device ID | K994379 |
| 510k Number | K994379 |
| Device Name: | EU-TTG IGA ELISA |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | SCIMEDX CORP. 400 FORD RD. Denville, NJ 07834 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus SCIMEDX CORP. 400 FORD RD. Denville, NJ 07834 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-27 |
| Decision Date | 2000-02-18 |