CREATININE REAGENT SET (KINETIC)

Alkaline Picrate, Colorimetry, Creatinine

TECH-NEAL SCIENTIFIC, INC.

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

Pre-market Notification Details

Device IDK880843
510k NumberK880843
Device Name:CREATININE REAGENT SET (KINETIC)
ClassificationAlkaline Picrate, Colorimetry, Creatinine
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 CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-26
Decision Date1988-04-05

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