WAKO L-TYPE UA F TEST

Acid, Uric, Uricase (colorimetric)

WAKO CHEMICALS, USA, INC.

The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako L-type Ua F Test.

Pre-market Notification Details

Device IDK993469
510k NumberK993469
Device Name:WAKO L-TYPE UA F TEST
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
ContactTonya Mallory
CorrespondentTonya Mallory
WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD Richmond,  VA  23237
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-13
Decision Date1999-11-09
Summary:summary

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