AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

WAKO CHEMICALS, USA, INC.

The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Automated Biochemical Analyzer (wak0-20r & 30r).

Pre-market Notification Details

Device IDK912024
510k NumberK912024
Device Name:AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
ContactEd Zior
CorrespondentEd Zior
WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-03
Decision Date1991-07-19

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