FDA 510(k) Application Details - K992685

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

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510(K) Number K992685
Device Name Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Applicant PHAMATECH
9265 ACTIVITY RD., #112-113
SAN DIEGO, CA 92126 US
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Contact CARL A MONGIOVI
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Regulation Number 000.0000

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Classification Product Code MVO
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Date Received 08/10/1999
Decision Date 10/06/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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