System, Test, Immunological, Antigen, Tumor

FDA product code MOI · 28 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.6010
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1997-05-23 – 2024-05-09

MOI 2024-05-09

Access BR Monitor

Applicant Beckman Coulter, Inc.

K number K240403

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MOI 2024-03-13

IMMULITE® 2000 BR-MA

Applicant Siemens Healthcare Diagnostics Products, Ltd.

K number K233946

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MOI 2020-09-04

Lumipulse G CA15-3

Applicant Fujirebio Diagnostics,Inc.

K number K192524

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MOI 2020-02-13

ADVIA Centaur BR

Applicant Siemens Healthcare Diagnostics, Inc.

K number K193489

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MOI 2019-11-22

ADVIA Centaur CA 15-3 assay

Applicant Siemens Healthcare Diagnostics, Inc.

K number K192777

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MOI 2018-06-22

Elecsys CA 15-3 II

Applicant Roche Diagnostics

K number K181492

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MOI 2018-02-20

Elecsys CA 15-3 II

Applicant Roche Diagnostics

K number K171605

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MOI 2011-04-18

DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605

Applicant Siemens Healthcare Diagnostics

K number K100344

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MOI 2007-10-26

ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647

Applicant Beckman Coulter, Inc.

K number K072612

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MOI 2004-12-22

ARCHITECT CA 15-3 ASSAY

Applicant Fujirebio Diagnostics,Inc.

K number K042732

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MOI 2004-02-03

BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647

Applicant Beckman Coulter, Inc.

K number K033036

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MOI 2002-11-12

CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

Applicant Bayer Diagnostics Corp.

K number K022178

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MOI 2002-03-28

IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR

Applicant Diagnostic Products Corp.

K number K013984

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MOI 2002-02-28

CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM

Applicant Bayer Diagnostics Corp.

K number K012357

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MOI 2001-08-16

AIA-PACK BRCA, ST AIA PACK BRCA

Applicant Tosoh Medics, Inc.

K number K010796

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MOI 2001-03-28

ELECSYSCA 15-3 II ASSAY

Applicant Roche Diagnostics Corp.

K number K010588

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MOI 2000-10-23

ELECSYS CA 15-3 TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K001468

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MOI 1999-02-02

VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK

Applicant Ortho-Clinical Diagnostics, Inc.

K number K983690

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MOI 1998-10-15

CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY

Applicant Chiron Diagnostics Corp.

K number K982680

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MOI 1998-07-10

ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)

Applicant Chiron Corp.

K number K981698

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MOI 1998-03-06

ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)

Applicant Chiron Corp.

K number K980190

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MOI 1997-12-01

THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

Applicant Bayer Corp.

K number K964703

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MOI 1997-11-10

IMX CA 15-3

Applicant Abbott Laboratories

K number K964407

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MOI 1997-10-31

TRUQUANT BR RIA

Applicant Biomira USA, Inc.

K number K965141

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MOI 1997-09-15

AXSYM CA 15-3

Applicant Abbott Laboratories

K number K963926

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MOI 1997-08-08

ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)

Applicant Chiron Diagnostics Corp.

K number K970695

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MOI 1997-07-17

CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER

Applicant Chiron Diagnostics Corp.

K number K971418

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MOI 1997-05-23

CENTOCOR CA 15-3 RIA MODEL NO. 800-033

Applicant Centocor, Inc.

K number K963803

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