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FDA 510(k) Application Details - K011347
Device Classification Name
Enzyme Immunoassay, Diphenylhydantoin
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510(K) Number
K011347
Device Name
Enzyme Immunoassay, Diphenylhydantoin
Applicant
SYVA CO.
3403 YERBA BUENA RD.
SAN JOSE, CA 95135-1500 US
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Contact
SUSAN COLLINS
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Regulation Number
862.3350
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Classification Product Code
DIP
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More FDA Info for this Product Code
Date Received
05/02/2001
Decision Date
05/17/2001
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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