WAKO(TM) PRETEST 8A

Azo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.)

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) Pretest 8a.

Pre-market Notification Details

Device IDK873553
510k NumberK873553
Device Name:WAKO(TM) PRETEST 8A
ClassificationAzo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.)
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 CodeJJB  
CFR Regulation Number862.1115 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-28
Decision Date1987-09-22

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