FDA 510(k) Application Details - K955153

Device Classification Name Drug Mixture Control Materials

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510(K) Number K955153
Device Name Drug Mixture Control Materials
Applicant BIO-RAD
3726 EAST MIRALOMA AVE.
ANAHEIM, CA 92806 US
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Contact DONNA CHAPMAN
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Regulation Number 862.3280

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Classification Product Code DIF
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Date Received 11/13/1995
Decision Date 02/05/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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