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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 K122838
Model 267, 268, 269, 268X
Device Name LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK
Applicant
BIO-RAD LABORATORIES
9500 jeronimo rd.
irvine,  CA  92618 2017
Contact suzanne parsons
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/17/2012
Decision Date 10/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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