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FDA 510(k) Application Details - K010045
Device Classification Name
Enzyme Immunoassay, Phencyclidine
More FDA Info for this Device
510(K) Number
K010045
Device Name
Enzyme Immunoassay, Phencyclidine
Applicant
ALFA SCIENTIFIC DESIGNS, INC.
12330 STOWE DR.
POWAY, CA 92064 US
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Contact
NAISHU WANG
Other 510(k) Applications for this Contact
Regulation Number
862.3100
More FDA Info for this Regulation Number
Classification Product Code
LCM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/05/2001
Decision Date
05/29/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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