FDA 510(k) Application Details - K993852

Device Classification Name Gas Chromatography, Methamphetamine

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510(K) Number K993852
Device Name Gas Chromatography, Methamphetamine
Applicant WORLDWIDE MEDICAL CORP.
1900 K ST. NW
WASHINGTON, DC 20006 US
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Contact LARRY R PILOT
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Regulation Number 862.3610

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Classification Product Code LAF
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Date Received 11/12/1999
Decision Date 11/29/2000
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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