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FDA 510(k) Application Details - K003687
Device Classification Name
Reagents, Test, Tetrahydrocannabinol
More FDA Info for this Device
510(K) Number
K003687
Device Name
Reagents, Test, Tetrahydrocannabinol
Applicant
MEDTOX DIAGNOSTICS, INC.
1238 ANTHONY RD.
BURLINGTON, NC 27215 US
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Contact
MICHAEL TURANCHIK
Other 510(k) Applications for this Contact
Regulation Number
862.3870
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Classification Product Code
DKE
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More FDA Info for this Product Code
Date Received
11/30/2000
Decision Date
12/22/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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