Medical Device Manufacturer · GB , Perth, Scotland

Quantase , Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1999

Recent clearances: QUANTASE TOTAL GALACTOSE SCREENING ASSAY, QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT, QUANTASE PHE/GAL SCREENING ASSAY

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Quantase , Ltd. Chemistry ✕

4 devices

1-4 of 4

Cleared Jun 19, 2000

QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT

Chemistry · 103d

Cleared Jun 21, 1999

QUANTASE TOTAL GALACTOSE SCREENING ASSAY

Chemistry · 115d

Cleared Jun 21, 1999

QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT

Chemistry · 112d

Cleared Feb 16, 1999

QUANTASE PHE/GAL SCREENING ASSAY

Chemistry · 62d