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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K961828
Device Name LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)
Applicant
BIO-RAD
3726 EAST MIRALOMA AVE.
ANAHEIM,  CA  92806
Applicant Contact ELIZABETH PLATT
Correspondent
BIO-RAD
3726 EAST MIRALOMA AVE.
ANAHEIM,  CA  92806
Correspondent Contact ELIZABETH PLATT
Regulation Number862.1660
Classification Product Code
JJT  
Date Received05/13/1996
Decision Date 06/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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