QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT

Enzymatic Methods, Galactose

QUANTASE LTD.

The following data is part of a premarket notification filed by Quantase Ltd. with the FDA for Quantase Total Galactose Screening Assay 500 Test Kit.

Pre-market Notification Details

Device IDK990654
510k NumberK990654
Device Name:QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
ClassificationEnzymatic Methods, Galactose
Applicant QUANTASE LTD. 3 RIVERVIEW BUSINESS PARK FRIARTON ROAD Perth, Scotland,  GB Ph2 8df
ContactR. Stewart Campbell
CorrespondentR. Stewart Campbell
QUANTASE LTD. 3 RIVERVIEW BUSINESS PARK FRIARTON ROAD Perth, Scotland,  GB Ph2 8df
Product CodeJIA  
CFR Regulation Number862.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-01
Decision Date1999-06-21

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