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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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