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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 K925151
Device Name LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3
Applicant
BIO-RAD
3726 EAST MIRALOMA AVE.
ANAHEIM,  CA  92806
Applicant Contact TEVA C ROTHWELL
Correspondent
BIO-RAD
3726 EAST MIRALOMA AVE.
ANAHEIM,  CA  92806
Correspondent Contact TEVA C ROTHWELL
Regulation Number862.1660
Classification Product Code
JJT  
Date Received10/13/1992
Decision Date 12/17/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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