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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 K080607
Device Name CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50416
INDIANAPOLIS,  IN  46250 -3831
Applicant Contact KATHIE J CUNNINGHAM
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50416
INDIANAPOLIS,  IN  46250 -3831
Correspondent Contact KATHIE J CUNNINGHAM
Regulation Number862.1150
Classification Product Code
JIX  
Date Received03/04/2008
Decision Date 05/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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