The following data is part of a premarket notification filed by Scimedx Corp. with the FDA for Ifa Kit For The Detection Of Endomysial Iga Anibodies Using Primate Umbilical Cord (puc)-ema/puc Lga..
| Device ID | K002107 |
| 510k Number | K002107 |
| Device Name: | IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | SCIMEDX CORP. 400 FORD RD. Denville, NJ 07834 |
| Contact | Gary Lehnus,ph.d |
| Correspondent | Gary Lehnus,ph.d 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 | 2000-07-12 |
| Decision Date | 2000-08-04 |