ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT

Nadh Oxidation/nad Reduction, Alt/sgpt

TRACE SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Alt (gpt) Ifcc 2-vial Reagent W/pyridoxyl Phosphat.

Pre-market Notification Details

Device IDK891469
510k NumberK891469
Device Name:ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
ClassificationNadh Oxidation/nad Reduction, Alt/sgpt
Applicant TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168,  AU
ContactP. J Ruthven
CorrespondentP. J Ruthven
TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168,  AU
Product CodeCKA  
CFR Regulation Number862.1030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-15
Decision Date1989-04-04

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