WAKO(TM) IGA-HA DIRECT

Iga, 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(tm) Iga-ha Direct.

Pre-market Notification Details

Device IDK880803
510k NumberK880803
Device Name:WAKO(TM) IGA-HA DIRECT
ClassificationIga, Antigen, Antiserum, Control
Applicant WAKO CHEMICALS, USA, INC. 12300 FORD RD. SUITE 130 Dallas,  TX  75234
ContactToshihiko Oda
CorrespondentToshihiko Oda
WAKO CHEMICALS, USA, INC. 12300 FORD RD. SUITE 130 Dallas,  TX  75234
Product CodeCZP  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-29
Decision Date1988-03-29

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