KING DIAGNOSTICS ALT (GPT) REAGENT

Nadh Oxidation/nad Reduction, Alt/sgpt

KING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for King Diagnostics Alt (gpt) Reagent.

Pre-market Notification Details

Device IDK922109
510k NumberK922109
Device Name:KING DIAGNOSTICS ALT (GPT) REAGENT
ClassificationNadh Oxidation/nad Reduction, Alt/sgpt
Applicant KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
ContactFrances Loh
CorrespondentFrances Loh
KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
Product CodeCKA  
CFR Regulation Number862.1030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-05
Decision Date1992-06-04

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