WAKO(TM) AUTOKIT ALP

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

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 Alp.

Pre-market Notification Details

Device IDK873333
510k NumberK873333
Device Name:WAKO(TM) AUTOKIT ALP
ClassificationNitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
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 CodeCJE  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-19
Decision Date1987-10-02

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