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FDA 510(k) Application Details - K994400
Device Classification Name
Thin Layer Chromatography, Metamphetamine
More FDA Info for this Device
510(K) Number
K994400
Device Name
Thin Layer Chromatography, Metamphetamine
Applicant
ALFA SCIENTIFIC DESIGNS, INC.
11494 SORRENTO VALLEY RD.,
SUITE F/M
SAN DIEGO, CA 92121 US
Other 510(k) Applications for this Company
Contact
NAISHU WANG
Other 510(k) Applications for this Contact
Regulation Number
862.3610
More FDA Info for this Regulation Number
Classification Product Code
DJC
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More FDA Info for this Product Code
Date Received
12/28/1999
Decision Date
08/04/2000
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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