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FDA 510(k) Application Details - K111927
Device Classification Name
Gas Chromatography, Methamphetamine
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510(K) Number
K111927
Device Name
Gas Chromatography, Methamphetamine
Applicant
PSYCHEMEDICS CORP.
5832 UPLANDER WAY
CULVER CITY, CA 90230 US
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Contact
VIRGINIA HILL
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Regulation Number
862.3610
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Classification Product Code
LAF
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More FDA Info for this Product Code
Date Received
07/06/2011
Decision Date
05/01/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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