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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K953448
Device Name ROCHE COBAS MICROS HEMATOLOGY ANALYZER
Applicant
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Applicant Contact RIAT SMITH
Correspondent
Roche Diagnostic Systems, Inc.
1080 Us Hwy. 202
Branchburg,  NJ  08876
Correspondent Contact RIAT SMITH
Regulation Number864.5220
Classification Product Code
GKZ  
Subsequent Product Codes
GKL   GKR   GKX   JWJ  
Date Received07/17/1995
Decision Date 10/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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