FDA 510(k) Application Details - K010226

Device Classification Name Thin Layer Chromatography, Metamphetamine

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510(K) Number K010226
Device Name Thin Layer Chromatography, Metamphetamine
Applicant MEDTOX DIAGNOSTICS, INC.
1238 ANTHONY RD.
BURLINGTON, NC 27215 US
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Contact MICHEAL TURANCHIK
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Regulation Number 862.3610

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Classification Product Code DJC
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Date Received 01/24/2001
Decision Date 06/01/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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