The following data is part of a premarket notification filed by Scimedx Corp. with the FDA for Eia Kit For The Detection Of Anti-mpo Antibodies.
| Device ID | K954062 |
| 510k Number | K954062 |
| Device Name: | EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | SCIMEDX CORP. 400 FORD RD. Denville, NJ 07834 |
| Contact | Thomas Britten |
| Correspondent | Thomas Britten SCIMEDX CORP. 400 FORD RD. Denville, NJ 07834 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-29 |
| Decision Date | 1996-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545029036 | K954062 | 000 |