FDA 510(k) Application Details - K993982

Device Classification Name Gas Chromatography, Methamphetamine

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510(K) Number K993982
Device Name Gas Chromatography, Methamphetamine
Applicant SYVA CO.
3403 YERBA BUENA RD.
P.O. BOX 49013
SAN JOSE, CA 95161-9013 US
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Contact PAUL L ROGERS
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Regulation Number 862.3610

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Classification Product Code LAF
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Date Received 11/24/1999
Decision Date 01/27/2000
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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