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FDA 510(k) Application Details - K974461
Device Classification Name
Enzyme Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K974461
Device Name
Enzyme Controls (Assayed And Unassayed)
Applicant
BIOSITE INCORPORATED
11030 ROSELLE ST.
SAN DIEGO, CA 92121 US
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Contact
JOHN F BRUNI
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJT
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More FDA Info for this Product Code
Date Received
11/25/1997
Decision Date
12/10/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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