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Miscellaneous
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart C—Microbiology Devices
CFR Sub-Part
Subpart D—Clinical Toxicology Test Systems
CFR Sub-Part
Subpart D—Serological Reagents
CFR Sub-Part
Subpart E—Immunology Laboratory Equipment and Reagents
CFR Sub-Part
Subpart E—Specimen Preparation Reagents
CFR Sub-Part
Subpart F—Automated and Semi-Automated Hematology Devices
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Subpart G—Tumor Associated Antigen immunological Test Systems
CFR Sub-Part
DHX
System, Test, Carcinoembryonic Antigen
2
Product Code
LOJ
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
2
Product Code
LTJ
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
2
Product Code
LTK
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
2
Product Code
MMW
System, Test, Tumor Marker, Monitoring, Bladder
2
Product Code
MOI
System, Test, Immunological, Antigen, Tumor
2
Product Code
K
24
0403
Access BR Monitor
2
Cleared 510(K)
K
23
3946
IMMULITE® 2000 BR-MA
2
Cleared 510(K)
K
19
2524
Lumipulse G CA15-3
2
Cleared 510(K)
K
19
3489
ADVIA Centaur BR
2
Cleared 510(K)
K
19
2777
ADVIA Centaur CA 15-3 assay
2
Cleared 510(K)
K
18
1492
Elecsys CA 15-3 II
2
Cleared 510(K)
K
17
1605
Elecsys CA 15-3 II
2
Cleared 510(K)
K
10
0344
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
2
Cleared 510(K)
K
07
2612
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
2
Cleared 510(K)
K
04
2732
ARCHITECT CA 15-3 ASSAY
2
Cleared 510(K)
K
03
3036
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
2
Cleared 510(K)
K
02
2178
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
2
Cleared 510(K)
K
01
3984
IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR
2
Cleared 510(K)
K
01
2357
CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM
2
Cleared 510(K)
K
01
0796
AIA-PACK BRCA, ST AIA PACK BRCA
2
Cleared 510(K)
K
01
0588
ELECSYSCA 15-3 II ASSAY
2
Cleared 510(K)
K
00
1468
ELECSYS CA 15-3 TEST SYSTEM
2
Cleared 510(K)
K
98
3690
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK
2
Cleared 510(K)
K
98
2680
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
2
Cleared 510(K)
K
98
1698
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
2
Cleared 510(K)
K
98
0190
ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)
2
Cleared 510(K)
K
96
4703
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
2
Cleared 510(K)
K
96
4407
IMX CA 15-3
2
Cleared 510(K)
K
96
5141
TRUQUANT BR RIA
2
Cleared 510(K)
K
96
3926
AXSYM CA 15-3
2
Cleared 510(K)
K
97
0695
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
2
Cleared 510(K)
K
97
1418
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
2
Cleared 510(K)
K
96
3803
CENTOCOR CA 15-3 RIA MODEL NO. 800-033
2
Cleared 510(K)
MSW
System, Test, Thyroglobulin
2
Product Code
MUT
Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)
2
Product Code
NCW
System, Test, Her-2/Neu, Monitoring
2
Product Code
NIG
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
2
Product Code
NSF
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
2
Product Code
NTY
System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
2
Product Code
NVA
Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma
2
Product Code
OAU
Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
2
Product Code
OIU
Test, Epithelial Ovarian Tumor Associated Antigen (He4)
2
Product Code
OVK
Cytokeratin Fragments 21-1 Eia Kit
2
Product Code
ONX
Ovarian Adnexal Mass Assessment Score Test System
2
Product Code
QTE
Thymidine Kinase Activity
2
Product Code
QXS
Chromogranin A
2
Product Code
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 27 June 2025 at 11:06 pm
IM
/
subpart-g—tumor-associated-antigen-immunological-test-systems
/
MOI
/
K982680
View Source
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K982680
510(k) Type
Traditional
Applicant
CHIRON DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/15/1998
Days to Decision
76 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Miscellaneous
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
Subpart D—Clinical Toxicology Test Systems
Subpart D—Serological Reagents
Subpart E—Immunology Laboratory Equipment and Reagents
Subpart E—Specimen Preparation Reagents
Subpart F—Automated and Semi-Automated Hematology Devices
Subpart F—Immunological Test Systems
Subpart G—Tumor Associated Antigen immunological Test Systems
DHX
System, Test, Carcinoembryonic Antigen
LOJ
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
LTJ
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
LTK
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
MMW
System, Test, Tumor Marker, Monitoring, Bladder
MOI
System, Test, Immunological, Antigen, Tumor
K
24
0403
Access BR Monitor
K
23
3946
IMMULITE® 2000 BR-MA
K
19
2524
Lumipulse G CA15-3
K
19
3489
ADVIA Centaur BR
K
19
2777
ADVIA Centaur CA 15-3 assay
K
18
1492
Elecsys CA 15-3 II
K
17
1605
Elecsys CA 15-3 II
K
10
0344
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
K
07
2612
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
K
04
2732
ARCHITECT CA 15-3 ASSAY
K
03
3036
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
K
02
2178
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K
01
3984
IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR
K
01
2357
CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K
01
0796
AIA-PACK BRCA, ST AIA PACK BRCA
K
01
0588
ELECSYSCA 15-3 II ASSAY
K
00
1468
ELECSYS CA 15-3 TEST SYSTEM
K
98
3690
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK
K
98
2680
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
K
98
1698
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
K
98
0190
ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)
K
96
4703
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K
96
4407
IMX CA 15-3
K
96
5141
TRUQUANT BR RIA
K
96
3926
AXSYM CA 15-3
K
97
0695
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
K
97
1418
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
K
96
3803
CENTOCOR CA 15-3 RIA MODEL NO. 800-033
MSW
System, Test, Thyroglobulin
MUT
Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)
NCW
System, Test, Her-2/Neu, Monitoring
NIG
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
NSF
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
NTY
System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
NVA
Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Mesothelioma
OAU
Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
OIU
Test, Epithelial Ovarian Tumor Associated Antigen (He4)
OVK
Cytokeratin Fragments 21-1 Eia Kit
ONX
Ovarian Adnexal Mass Assessment Score Test System
QTE
Thymidine Kinase Activity
QXS
Chromogranin A
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
IM
/
subpart-g—tumor-associated-antigen-immunological-test-systems
/
MOI
/
K982680
View Source
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K982680
510(k) Type
Traditional
Applicant
CHIRON DIAGNOSTICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/15/1998
Days to Decision
76 days
Submission Type
Summary