FDA 510(k) Application Details - K012907

Device Classification Name Drug Mixture Control Materials

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510(K) Number K012907
Device Name Drug Mixture Control Materials
Applicant CLINICAL CONTROLS
12038 CENTRALIA RD.
SUITE C
HAWAIIAN GARDENS, CA 90716 US
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Contact JAMES F GODFREY
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Regulation Number 862.3280

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Classification Product Code DIF
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Date Received 08/29/2001
Decision Date 09/28/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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