Medical Device Manufacturer · US , Mchenry , IL

Simmler, Inc. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1980

23

Total

23

Cleared

0

Denied

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

21 devices

1-12 of 21

Cleared Feb 11, 1988

MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)

Chemistry · 72d

Cleared Jan 07, 1988

MULTICHEM HDL PRECIPITATING REAGENT #S0914

Chemistry · 44d

Cleared Dec 18, 1987

MULTICHEM CHLORIDE REAGENT S0933

Chemistry · 24d

Cleared Nov 25, 1987

MULTICHEM (R) TOTAL BILIRUBIN

Chemistry · 36d

Cleared Oct 29, 1987

MULTICHEM ALBUMIN REAGENT S0902

Chemistry · 24d

Cleared Oct 28, 1987

MULTICHEM INORGANIC PHOSPHOROUS S0923

Chemistry · 23d

Cleared Oct 20, 1987

MULTICHEM CREATININE REAGENT S0917

Chemistry · 35d

Cleared Oct 07, 1987

MULTICHEM ALKALINE PHOSPHATASE (S0903)

Chemistry · 21d

Cleared Oct 02, 1987

MULTICHEM CALCIUM S0910

Chemistry · 18d

Cleared Jun 11, 1987

MULTICHEM LDH-L REAGENT

Chemistry · 16d

Cleared Jun 05, 1987

MULTICHEM TOTAL PROTEIN REAGENT #S0928

Chemistry · 14d

Cleared Jun 05, 1987

MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919

Chemistry · 14d