FDA 510(k) Application Details - K972618

Device Classification Name Thin Layer Chromatography, Cocaine

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510(K) Number K972618
Device Name Thin Layer Chromatography, Cocaine
Applicant PHAMATECH
9520 PADGETT ST. #108-110
SAN DIEGO, CA 92126 US
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Contact CARL MONGIOVI
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Regulation Number 862.3250

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Classification Product Code DMN
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Date Received 07/11/1997
Decision Date 08/08/1997
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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