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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K922043
Device Name ROCHE CALIBRATOR SERUM
Applicant
Roche Diagnostic Systems, Inc.
1080 Us Highway 202
Branchburg,  NJ  08876 -3771
Applicant Contact CAROL L KRIEGER
Correspondent
Roche Diagnostic Systems, Inc.
1080 Us Highway 202
Branchburg,  NJ  08876 -3771
Correspondent Contact CAROL L KRIEGER
Regulation Number862.1150
Classification Product Code
JIX  
Date Received05/01/1992
Decision Date 06/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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