The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Cobas Micros Hematology Analyzer.
| Device ID | K953448 |
| 510k Number | K953448 |
| Device Name: | ROCHE COBAS MICROS HEMATOLOGY ANALYZER |
| Classification | Counter, Differential Cell |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Contact | Riat Smith |
| Correspondent | Riat Smith ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Product Code | GKZ |
| Subsequent Product Code | GKL |
| Subsequent Product Code | GKR |
| Subsequent Product Code | GKX |
| Subsequent Product Code | JWJ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-17 |
| Decision Date | 1995-10-13 |