FDA 510(k) Application Details - K121143

Device Classification Name Drug Mixture Control Materials

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510(K) Number K121143
Device Name Drug Mixture Control Materials
Applicant Bio-Rad Laboratories
9500 JERONIMO RD.
IRVINE, CA 92618-2017 US
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Contact SUZSNNE PARSONS
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Regulation Number 862.3280

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Classification Product Code DIF
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Date Received 04/16/2012
Decision Date 05/18/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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