Medical Device Manufacturer · US , Nashua , NH

Enzyme Technology, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1989

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Enzyme Technology, Inc. Chemistry ✕

5 devices

1-5 of 5

Cleared Jan 30, 1992

CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL

Chemistry · 267d

Cleared Dec 18, 1991

URIC ACID (URICASE) REAGENT, UNIVERSAL

Chemistry · 224d

Cleared Mar 11, 1991

GLUCOSE (HK) REAGENT, UNIVERSAL

Chemistry · 111d

Cleared Dec 11, 1990

TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL

Chemistry · 21d

Cleared Dec 12, 1989

CHOLESTEROL, UNIVERSAL ET

Chemistry · 54d