FDA 510(k) Application Details - K983127

Device Classification Name Drug Mixture Control Materials

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510(K) Number K983127
Device Name Drug Mixture Control Materials
Applicant MEDICAL ANALYSIS SYSTEMS, INC.
LINCOLN TECHNOLOGY PARK
542 FLYNN RD.
CAMARILLO, CA 93012 US
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Contact MARY THORSNESS
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Regulation Number 862.3280

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Classification Product Code DIF
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Date Received 09/08/1998
Decision Date 09/14/1998
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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