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FDA 510(k) Application Details - K132076
Device Classification Name
Reagent, Russel Viper Venom
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510(K) Number
K132076
Device Name
Reagent, Russel Viper Venom
Applicant
DSRV, INC.
780 PARK NORTH BLVD.
SUITE 100
Clarkston, GA 30021 US
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Contact
LAWANDA WASHINGTON
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Regulation Number
864.8950
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Classification Product Code
GIR
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More FDA Info for this Product Code
Date Received
07/03/2013
Decision Date
01/10/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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