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FDA 510(k) Application Details - K972697
Device Classification Name
Ige, Antigen, Antiserum, Control
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510(K) Number
K972697
Device Name
Ige, Antigen, Antiserum, Control
Applicant
TOSOH MEDICS, INC.
373 VINTAGE PARK DR.
SUITE D
FOSTER CITY, CA 94404 US
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Contact
LORI ROBINSON
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Regulation Number
866.5510
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Classification Product Code
DGC
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More FDA Info for this Product Code
Date Received
07/18/1997
Decision Date
10/03/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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