URIC ACID REAGENT SET

Acid, Uric, Uricase (colorimetric)

TECH-NEAL SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Tech-neal Scientific, Inc. with the FDA for Uric Acid Reagent Set.

Pre-market Notification Details

Device IDK880277
510k NumberK880277
Device Name:URIC ACID REAGENT SET
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant TECH-NEAL SCIENTIFIC, INC. 817 OAKWOOD DR. Westmont,  IL  60559
ContactArun Sanghavi
CorrespondentArun Sanghavi
TECH-NEAL SCIENTIFIC, INC. 817 OAKWOOD DR. Westmont,  IL  60559
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-21
Decision Date1988-04-18

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