CK-NAC 2-VIAL REAGENT W/SUBSTRATE START

Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

TRACE SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Ck-nac 2-vial Reagent W/substrate Start.

Pre-market Notification Details

Device IDK891470
510k NumberK891470
Device Name:CK-NAC 2-VIAL REAGENT W/SUBSTRATE START
ClassificationNad Reduction/nadh Oxidation, Cpk Or Isoenzymes
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 CodeCGS  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-15
Decision Date1989-05-09

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