The following data is part of a premarket notification filed by Scimedx Corp. with the FDA for Eurospital Eu-ttg Iga Umana.
| Device ID | K010625 |
| 510k Number | K010625 |
| Device Name: | EUROSPITAL EU-TTG IGA UMANA |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | SCIMEDX CORP. 400 FORD RD. BLDG. 100 Denville, NJ 07834 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus SCIMEDX CORP. 400 FORD RD. BLDG. 100 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 | 2001-03-02 |
| Decision Date | 2001-04-24 |