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FDA 510(k) Application Details - K010934
Device Classification Name
Enzyme Immunoassay, Barbiturate
More FDA Info for this Device
510(K) Number
K010934
Device Name
Enzyme Immunoassay, Barbiturate
Applicant
SYVA CO., DADE BEHRING, INC.
P.O. BOX 49013
3403 YERBA BUENA ROAD
SAN JOSE, CA 95135 US
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Contact
VIRGINIA SINGER
Other 510(k) Applications for this Contact
Regulation Number
862.3150
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Classification Product Code
DIS
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More FDA Info for this Product Code
Date Received
03/28/2001
Decision Date
04/20/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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