The following data is part of a premarket notification filed by Scimedx Corp. with the FDA for Scimedx Phase Ii Mpo Igg Antibody Eia.
| Device ID | K010289 |
| 510k Number | K010289 |
| Device Name: | SCIMEDX PHASE II MPO IGG ANTIBODY EIA |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| 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 | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-31 |
| Decision Date | 2001-03-07 |