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FDA 510(k) Application Details - K073078
Device Classification Name
High Pressure Liquid Chromatography, Methamphetamine
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510(K) Number
K073078
Device Name
High Pressure Liquid Chromatography, Methamphetamine
Applicant
AMERICAN BIO MEDICA CORP.
603 HERON DR.
UNIT 3
LOGAN TOWNSHIP, NJ 08085 US
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Contact
RICH REILLY
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Regulation Number
862.3610
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Classification Product Code
LAG
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More FDA Info for this Product Code
Date Received
10/31/2007
Decision Date
05/30/2008
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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