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FDA 510(k) Application Details - K994404
Device Classification Name
Liquid Chromatography, Morphine
More FDA Info for this Device
510(K) Number
K994404
Device Name
Liquid Chromatography, Morphine
Applicant
ALFA SCIENTIFIC DESIGNS, INC.
11494 SORRENTO VALLEY RD.,
SUITE F/M
SAN DIEGO, CA 92121 US
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Contact
NAISHU WANG
Other 510(k) Applications for this Contact
Regulation Number
862.3640
More FDA Info for this Regulation Number
Classification Product Code
DPK
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More FDA Info for this Product Code
Date Received
12/28/1999
Decision Date
07/05/2000
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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