WAKO AUTOKIT CRP NEW

C-reactive Protein, Antigen, Antiserum, And 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 Crp New.

Pre-market Notification Details

Device IDK955156
510k NumberK955156
Device Name:WAKO AUTOKIT CRP NEW
ClassificationC-reactive Protein, Antigen, Antiserum, And 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 CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-13
Decision Date1996-02-16

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