The following data is part of a premarket notification filed by Scimedx Corp. with the FDA for Eia Kit For The Detection Of Gbm Antibodies.
| Device ID | K953495 |
| 510k Number | K953495 |
| Device Name: | EIA KIT FOR THE DETECTION OF GBM ANTIBODIES |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| 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 | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-26 |
| Decision Date | 1996-04-10 |