ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID

Glucose Dehydrogenase, Glucose

TRACE SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Enzymatic Glucose Reagent Single Vial Glucose Oxid.

Pre-market Notification Details

Device IDK860726
510k NumberK860726
Device Name:ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
ClassificationGlucose Dehydrogenase, Glucose
Applicant TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168,  AU
ContactW. C Riddle
CorrespondentW. C Riddle
TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168,  AU
Product CodeLFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-26
Decision Date1986-04-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845275002409 K860726 000

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