FDA 510(k) Application Details - K031392

Device Classification Name Alcohol Control Materials

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510(K) Number K031392
Device Name Alcohol Control Materials
Applicant MEDICAL ANALYSIS SYSTEMS, INC.
5300 ADOLFO RD.
CAMARILLO, CA 93012 US
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Contact PENNY M LAYMAN
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Regulation Number 862.3280

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Classification Product Code DKC
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Date Received 05/02/2003
Decision Date 07/01/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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