FDA 510(k) Application Details - K990786

Device Classification Name High Pressure Liquid Chromatography, Methamphetamine

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510(K) Number K990786
Device Name High Pressure Liquid Chromatography, Methamphetamine
Applicant PRINCETON BIOMEDITECH CORP.
4242 U.S. RT. 1
MONMOUTH JUNCTION, NJ 08852-1905 US
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Contact JEMO KANG
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Regulation Number 862.3610

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Classification Product Code LAG
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Date Received 03/10/1999
Decision Date 03/26/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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