ALT (SGPT) REAGENT SET

Nadh Oxidation/nad Reduction, Alt/sgpt

TECH-NEAL SCIENTIFIC, INC.

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

Pre-market Notification Details

Device IDK880275
510k NumberK880275
Device Name:ALT (SGPT) REAGENT SET
ClassificationNadh Oxidation/nad Reduction, Alt/sgpt
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 CodeCKA  
CFR Regulation Number862.1030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-21
Decision Date1988-03-01

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