COULTER ACCU-ZYME II GPT REAGENT

Nadh Oxidation/nad Reduction, Alt/sgpt

COULTER ELECTRONICS, INC.

The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Accu-zyme Ii Gpt Reagent.

Pre-market Notification Details

Device IDK790522
510k NumberK790522
Device Name:COULTER ACCU-ZYME II GPT REAGENT
ClassificationNadh Oxidation/nad Reduction, Alt/sgpt
Applicant COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCKA  
CFR Regulation Number862.1030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-03-09
Decision Date1979-05-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.