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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K972214
Device Name ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
Applicant
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Highway 202
Somerville,  NJ  08876 -3771
Applicant Contact JAMES W HAYNES
Correspondent
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Highway 202
Somerville,  NJ  08876 -3771
Correspondent Contact JAMES W HAYNES
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/12/1997
Decision Date 06/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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