WAKO(TM) AUTOKIT TOTAL PROTEIN

Biuret (colorimetric), Total Protein

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) Autokit Total Protein.

Pre-market Notification Details

Device IDK880312
510k NumberK880312
Device Name:WAKO(TM) AUTOKIT TOTAL PROTEIN
ClassificationBiuret (colorimetric), Total Protein
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 CodeCEK  
CFR Regulation Number862.1635 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-25
Decision Date1988-03-24

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