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 |