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FDA 510(k) Application Details - K210212
Device Classification Name
Gas Chromatography, Methamphetamine
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510(K) Number
K210212
Device Name
Gas Chromatography, Methamphetamine
Applicant
Psychemedics Corporation
5832 Uplander Way
Culver City, CA 90230 US
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Contact
Neil Stowe
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Regulation Number
862.3610
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Classification Product Code
LAF
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Date Received
01/27/2021
Decision Date
12/15/2021
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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