Medical Device Manufacturer · US , Westford , MA

Direct Solutions - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1995

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Direct Solutions Chemistry ✕

3 devices

1-3 of 3

Cleared Nov 08, 1996

HEMOCUE GLUCOLIN

Chemistry · 39d

Cleared Nov 01, 1996

HEMOCUE GLUCOTROL

Chemistry · 32d

Cleared Dec 26, 1995

EUROTROL GAS - ISE CONTROL

Chemistry · 36d