Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

Cleared Jun 10, 1988

COBAS EIA(TM) PHOTOMETER

K881877 · JJQ

Chemistry · 37d

Cleared Dec 22, 1987

FRUCTOSAMINE TEST (ROCHE)

K854010 · LCP

Chemistry · 813d

Cleared Oct 20, 1987

ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL

K873250 · CIJ

Chemistry · 64d

Cleared May 28, 1987

COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS

K871484 · LGS

Chemistry · 43d

Cleared Jul 12, 1985

ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA

K852473 · JGS

Chemistry · 31d

Cleared May 10, 1985

COBAS CALIBRATOR SERUM

K850859 · JIX

Chemistry · 70d

Cleared May 02, 1985

COBAS MIRA

K851172 · JJF

Chemistry · 41d

Cleared Mar 22, 1985

COBAS FP REAGENTS FOR CARBAMAZEPINE

K850807 · KLT

Chemistry · 23d

Cleared Mar 14, 1985

ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS

K850334 · CHJ

Chemistry · 45d

Cleared Feb 27, 1985

ROCHE STANDARDS FOR CHLORIDE & CO2

K850396 · JIX

Chemistry · 26d

Cleared Jan 18, 1985

ROCHE REAGENTS REAGENT FOR URIC ACID

K844986 · CDO

Chemistry · 23d

Cleared Jan 18, 1985

ROCHE REAGENTS REAGENT FOR CO2

K844987 · KHS

Chemistry · 23d

Cleared Nov 05, 1984

ROCHE REAGENT FOR AST

K843109 · CIT

Chemistry · 90d

Cleared Oct 05, 1984

ROCHE REAGENT FOR ALT

K843111 · CKA

Chemistry · 59d

Cleared Sep 13, 1984

ROCHE STANDARDS FOR URIC ACID

K843112 · JIT

Chemistry · 37d

Cleared Sep 04, 1984

ROCHE STANDARDS FOR CHOLESTEROL

K843110 · JIS

Chemistry · 28d

Cleared Feb 27, 1984

CK-NAC REAGENT

K834502 · CGS

Chemistry · 68d

Cleared May 09, 1983

COBAS STANDARDS FOR GLUCOSE & BUN

K831030 · JIX

Chemistry · 40d