WAKO(TM) FE C

Photometric Method, Iron (non-heme)

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) Fe C.

Pre-market Notification Details

Device IDK874263
510k NumberK874263
Device Name:WAKO(TM) FE C
ClassificationPhotometric Method, Iron (non-heme)
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 CodeJIY  
CFR Regulation Number862.1410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-20
Decision Date1987-11-23

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