The following data is part of a premarket notification filed by Scimedx Corp. with the FDA for Phase Ii Gbm Igg Antibody Eia Test.
| Device ID | K011348 |
| 510k Number | K011348 |
| Device Name: | PHASE II GBM IGG ANTIBODY EIA TEST |
| Classification | Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) |
| 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 | MVJ |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-02 |
| Decision Date | 2001-06-25 |