WAKO AUTOKIT C4

Complement C4, Antigen, Antiserum, Control

WAKO CHEMICALS, USA, INC.

The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Autokit C4.

Pre-market Notification Details

Device IDK010325
510k NumberK010325
Device Name:WAKO AUTOKIT C4
ClassificationComplement C4, Antigen, Antiserum, Control
Applicant WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
ContactTonya Mallory
CorrespondentTonya Mallory
WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
Product CodeDBI  
CFR Regulation Number866.5240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-02
Decision Date2001-06-25

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