KING DIAGNOSTICS URIC ACID TEST

Acid, Uric, Uricase (colorimetric)

KING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for King Diagnostics Uric Acid Test.

Pre-market Notification Details

Device IDK862208
510k NumberK862208
Device Name:KING DIAGNOSTICS URIC ACID TEST
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
ContactFrances K Loh
CorrespondentFrances K Loh
KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-10
Decision Date1986-07-08

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