FDA 510(k) Application Details - K014192

Device Classification Name Kit, Test, Multiple, Drugs Of Abuse, Over The Counter

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510(K) Number K014192
Device Name Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
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 000.0000

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Classification Product Code MVO
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Date Received 12/21/2001
Decision Date 05/23/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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