FDA 510(k) Application Details - K011185

Device Classification Name Thin Layer Chromatography, Metamphetamine

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510(K) Number K011185
Device Name Thin Layer Chromatography, Metamphetamine
Applicant PSYCHEMEDICS CORP.
5832 UPLANDER WAY
CULVER CITY, CA 90230 US
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Contact WILLIAM R TISTLE
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Regulation Number 862.3610

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Classification Product Code DJC
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Date Received 04/18/2001
Decision Date 01/24/2002
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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