FDA 510(k) Application Details - K972577

Device Classification Name Thin Layer Chromatography, Amphetamine

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510(K) Number K972577
Device Name Thin Layer Chromatography, Amphetamine
Applicant PHAMATECH
9265 ACTIVITY RD., #112-113
SAN DIEGO, CA 92126 US
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Contact CARL MONGIOVI
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Regulation Number 862.3100

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Classification Product Code DIT
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Date Received 07/10/1997
Decision Date 08/20/1997
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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