Medical Device Manufacturer · US , Newark, , DE

Dade Behring, Inc. - FDA 510(k) Cleared Devices

343 submissions · 343 cleared · Since 1978

343

Total

343

Cleared

0

Denied

52 devices

26-50 of 52

Cleared Aug 07, 2003

Immunology · 38d

Cleared May 15, 2003

TPSA FLEX REAGENT CARTRIDGE

Immunology · 16d

Cleared Feb 13, 2003

Immunology · 69d

Cleared Jun 21, 2002

DIMENSION TPSA CALIBRATOR, MODEL #RC459

Immunology · 87d

Cleared Jun 10, 2002

MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2

Immunology · 40d

Cleared Feb 28, 2001

DIMENSION PSA FLEX REAGENT CARTRIDGE

Immunology · 68d

Cleared Feb 14, 2001

RCRP FLEX REAGENT CARTRIDGE

Immunology · 104d

Cleared Nov 20, 2000

N LATEX B2-MICROGLOBULIN

Immunology · 80d

Cleared Sep 26, 2000

BN PROSPEC SYSTEM

Immunology · 119d

Cleared Mar 01, 2000

DIMENSION SPECIAL PROTEIN CALIBRATOR

Immunology · 71d

Cleared Mar 01, 2000

DIMENSION C4 FLEX REAGENT CARTRIDGE

Immunology · 71d

Cleared Mar 01, 2000

DIMENSION C3 FLEX REAGENT CARTRIDGE

Immunology · 71d

Cleared Feb 04, 2000

DIMENSION TRNF FLEX REAGENT CARTRIDGE

Immunology · 45d

Cleared Nov 23, 1999

N LATEX FERRITIN

Immunology · 54d

Cleared Oct 25, 1999

DADE BEHRING N HIGH SENSITIVITY CRP ASSAY

Immunology · 187d

Cleared Aug 02, 1999

N LATEX STFR REAGENT

Immunology · 117d

Cleared Jul 07, 1999

N LATEX IGE MONO REAGENT

Immunology · 43d

Cleared Apr 16, 1999

REVISED C-REACTIVE PROTEIN CALIBRATOR

Immunology · 35d

Cleared Apr 16, 1999

REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE

Immunology · 35d

Cleared Mar 25, 1999

IGG FLEX REAGENT CARTRIDGE

Immunology · 31d

Cleared Mar 25, 1999

IMMUNOGLOBULIN A TEST SYSTEM

Immunology · 31d

Cleared Mar 22, 1999

IGM FLEX REAGENT CARTRIDGE

Immunology · 28d

Cleared Mar 22, 1999

DIMENSION SPECIAL PROTEIN CALIBRATOR

Immunology · 28d

Cleared Dec 14, 1998

STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK

Immunology · 28d

Cleared Dec 10, 1998

MYOGLOBIN FLEX REAGENT CARTRIDGE

Immunology · 17d