FDA 510(k) Application Details - K022388

Device Classification Name Thin Layer Chromatography, Metamphetamine

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510(K) Number K022388
Device Name Thin Layer Chromatography, Metamphetamine
Applicant STARPLEX SCIENTIFIC, INC.
163 CABOT ST.
BEVERLY, MA 01915 US
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Contact FRAN WHITE
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Regulation Number 862.3610

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Classification Product Code DJC
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Date Received 07/23/2002
Decision Date 02/27/2003
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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