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FDA 510(k) Application Details - K101973
Device Classification Name
Gas Chromatography, Methamphetamine
More FDA Info for this Device
510(K) Number
K101973
Device Name
Gas Chromatography, Methamphetamine
Applicant
OMEGA LABORATORIES, INC.
PO BOX 506
SOUTH LYON, MI 48178 US
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Contact
ROBERT J BARD
Other 510(k) Applications for this Contact
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
07/13/2010
Decision Date
08/16/2011
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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