The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Cobas-fp Reagents For Vancomycin.
| Device ID | K953528 |
| 510k Number | K953528 |
| Device Name: | ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN |
| Classification | Radioimmunoassay, Vancomycin |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Contact | Rita Smith |
| Correspondent | Rita Smith ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Product Code | LEH |
| CFR Regulation Number | 862.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-27 |
| Decision Date | 1995-09-12 |