Medical Device Manufacturer · US , Mchenry , IL

Environmental Chemical Specialties - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1977

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - Environmental Chemical Specialties Chemistry ✕

14 devices

1-14 of 14

Cleared Oct 02, 1981

Chemistry · 17d

Cleared Jul 15, 1981

Chemistry · 20d

Cleared Jul 10, 1981

ANTI-ARRHYTHMIC CONTROL LEVELS I & II

Chemistry · 15d

Cleared Jul 10, 1981

TDM ANTI-CONVULSANT CONTROL LEVELS I-II

Chemistry · 15d

Cleared Jan 02, 1981

GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT)

Chemistry · 25d

Cleared Sep 16, 1980

SPINAL FLUID CONTROL(HUMAN)

Chemistry · 43d

Cleared Jul 21, 1980

TOTAL PROTEIN TEST

Chemistry · 76d

Cleared Dec 06, 1979

QUANTITATIVE CONTROL URINE I (HUMAN)

Chemistry · 10d

Cleared Dec 06, 1979

ELEVATED LIPID CONTROL

Chemistry · 10d

Cleared Dec 06, 1979

QUANTITATIVE CONTROL URINE II (HUMAN)

Chemistry · 10d

Cleared May 03, 1978

LYPOPROTEIN CHOLESTEROL TEST KIT

Chemistry · 90d

Cleared Jul 21, 1977

CHOLESTEROL KIT

Chemistry · 38d

Cleared Jul 12, 1977

TRIGLYCERIDE KIT

Chemistry · 29d

Cleared Jan 25, 1977

Chemistry · 29d