FDA 510(k) Application Details - K000979

Device Classification Name Gas Chromatography, Methamphetamine

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510(K) Number K000979
Device Name Gas Chromatography, Methamphetamine
Applicant REDWOOD BIOTECH, INC.
1206 SESAME DR.
SUNNYVALE, CA 94087 US
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Contact JANIS FREESTONE
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Regulation Number 862.3610

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Classification Product Code LAF
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Date Received 03/27/2000
Decision Date 04/10/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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