WAKO(TM) MICRO-ALBUMIN

Turbidimetric Method, Protein Or Albumin (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) Micro-albumin.

Pre-market Notification Details

Device IDK902216
510k NumberK902216
Device Name:WAKO(TM) MICRO-ALBUMIN
ClassificationTurbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
Applicant WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
ContactToshihiko Oda
CorrespondentToshihiko Oda
WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
Product CodeJIQ  
CFR Regulation Number862.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-16
Decision Date1990-06-18

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