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FDA 510(k) Application Details - K973547
Device Classification Name
Fluorometer, For Clinical Use
More FDA Info for this Device
510(K) Number
K973547
Device Name
Fluorometer, For Clinical Use
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
862.2560
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Classification Product Code
KHO
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More FDA Info for this Product Code
Date Received
09/18/1997
Decision Date
01/13/1998
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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