Medical Device Manufacturer · US , Mchenry , IL

Roche Analytical Instruments, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1980

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Roche Analytical Instruments, Inc. Chemistry ✕

11 devices

1-11 of 11

Cleared Jul 14, 1980

COBAS CK-NAC REAGENT

Chemistry · 42d

Cleared Jul 08, 1980

COBAS REAGENT FOR A-AMYLASE

Chemistry · 36d

Cleared Jul 08, 1980

COBAS REAGENT FOR TRIGLYCERIDES & COBAS

Chemistry · 36d

Cleared Jun 30, 1980

COBAS REAGENT FOR CHOLESTEROL

Chemistry · 28d

Cleared Jun 30, 1980

COBAS REAGENT FOR GLUCOSE RAPID

Chemistry · 28d

Cleared Jun 26, 1980

COBAS REAGENTS FOR URIC ACID

Chemistry · 30d

Cleared Jun 20, 1980

COBAS REAGENT FOR AST (SGOT)

Chemistry · 39d

Cleared Jun 20, 1980

COBAS REAGENT FOR ALKALINE PHOSPHATASE

Chemistry · 24d

Cleared Jun 17, 1980

COBAS REAGENT FOR BUN

Chemistry · 36d

Cleared Jun 09, 1980

COBAS TOTAL BILIRUBIN REAGENT & DILUENT

Chemistry · 28d

Cleared Jun 09, 1980

COBAS REAGENT FOR ALT (GPT)

Chemistry · 28d