FDA 510(k) Application Details - K991504

Device Classification Name Gas Chromatography, Methamphetamine

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510(K) Number K991504
Device Name Gas Chromatography, Methamphetamine
Applicant REDWOOD BIOTECH, INC.
2440 LEGHORN ST.
MOUNTAIN VIEW, CA 94043 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 04/29/1999
Decision Date 07/22/1999
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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