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FDA 510(k) Application Details - K971103
Device Classification Name
Fluorometer, For Clinical Use
More FDA Info for this Device
510(K) Number
K971103
Device Name
Fluorometer, For Clinical Use
Applicant
TOSOH MEDICS, INC.
373 VINTAGE PARK DR.
SUITE D
FOSTER CITY, CA 94404 US
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Contact
LORI ROBINSON
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
03/26/1997
Decision Date
06/27/1997
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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