Beckman Coulter, Inc. - FDA 510(k) Cleared Devices

Cleared Aug 19, 2005

FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020

K052082 · JMG

Immunology · 17d

Cleared May 06, 2005

PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION...

K050119 · JKM

Immunology · 108d

Cleared Feb 03, 2004

BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS,...

K033036 · MOI

Immunology · 127d

Cleared Dec 29, 2003

GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS,...

K033038 · NIG

Immunology · 91d

Cleared Aug 07, 2003

SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS...

K032035 · CZW

Immunology · 37d

Cleared May 06, 2003

ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS

K031270 · DHX

Immunology · 15d

Cleared May 02, 2003

ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

K031269 · MSW

Immunology · 11d

Cleared May 02, 2003

ACCESS OV MONITOR ASSAY

K031297 · LTK

Immunology · 8d

Cleared Feb 24, 2003

IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR

K024210 · DGC

Immunology · 66d

Cleared Dec 11, 2002

ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY

K023597 · LTK

Immunology · 44d

Cleared Jul 19, 2002

SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT

K021572 · DCN

Immunology · 66d

Cleared Sep 07, 2001

ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY...

K012208 · DDC

Immunology · 53d

Cleared May 10, 2001

BECKMAN COULTER DNASE B CALIBRATOR

K010696 · JIS

Immunology · 63d

Cleared Apr 11, 2001

VIGIL DNASE B CONTROL

K010693 · JJX

Immunology · 34d

Cleared Apr 05, 2001

IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT

K010236 · DCK

Immunology · 70d

Cleared Mar 05, 2001

VIGIL SEROLOGY CONTROL LEVEL C

K010358 · JJY

Immunology · 27d

Cleared Oct 19, 2000

ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER

K002905 · MSW

Immunology · 31d

Cleared Feb 01, 2000

BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION...

K993547 · CFN

Immunology · 105d

Cleared Feb 01, 2000

BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION...

K993549 · CFN

Immunology · 105d

Cleared Jan 18, 2000

ACCESS HYBRITECH PSA QC, MODEL 37209

K994200 · JJX

Immunology · 36d

Cleared Jan 05, 2000

ACCESS HYBRITECH FREE PSA QC, MODEL 37219

K993210 · JJX

Immunology · 103d

Cleared Nov 26, 1999

SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS

K993023 · JJY

Immunology · 78d

Cleared May 03, 1999

ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT

K990704 · DCK

Immunology · 60d

Cleared Dec 14, 1998

IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY...

K983340 · DBF

Immunology · 82d

Cleared Nov 25, 1998

IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT

K983895 · JZG

Immunology · 22d