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FDA 510(k) Application Details - K993980
Device Classification Name
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
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510(K) Number
K993980
Device Name
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Applicant
SYVA CO.
3403 YERBA BUENA RD.
SAN JOSE, CA 95161-9013 US
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Contact
PAUL L ROGERS
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Regulation Number
862.3040
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Classification Product Code
DML
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More FDA Info for this Product Code
Date Received
11/24/1999
Decision Date
02/01/2000
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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