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Innolitics
Anesthesiology
Review Panel
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Review Panel
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Review Panel
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Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
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—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Serological Reagents
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
JMG
Radioimmunoassay (Two-Site Solid Phase), Ferritin
2
Product Code
K
23
4052
Access Ferritin
2
Cleared 510(K)
K
05
2082
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
2
Cleared 510(K)
K
96
4282
TINA-QUANT FERRITIN ASSAY
2
Cleared 510(K)
K
97
1833
ELECSYS FERRITIN
2
Cleared 510(K)
K
96
3498
FERR FLEX REAGENT CARTRIDGE
2
Cleared 510(K)
K
95
0393
ACE(TM) CEDIA(R) FERRITIN ASSAY
2
Cleared 510(K)
K
92
6221
ACCESS FERRITIN ASSAY
2
Cleared 510(K)
K
92
5848
IMMULITE FERRITIN
2
Cleared 510(K)
K
92
0829
COBAS CORE FERRITIN EIA
2
Cleared 510(K)
K
92
0318
CEDIA FERRITIN ASSAY
2
Cleared 510(K)
K
90
2997
MILENIA (TM) FERRITIN
2
Cleared 510(K)
K
89
0697
RIA-GNOST FERRITIN
2
Cleared 510(K)
K
88
1138
CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.
2
Cleared 510(K)
K
87
3730
MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT
2
Cleared 510(K)
K
87
2955
DELFIA(TM) FERRITIN KIT
2
Cleared 510(K)
K
84
0460
CORNINGS MAGIC FERRITIN RADIOIMMUNO-
2
Cleared 510(K)
K
81
0799
QUANTIMUNE FERRITIN IRMA
2
Cleared 510(K)
K
79
2588
TERRITIN RIA KIT
2
Cleared 510(K)
K
79
1096
RADIOIMMUNOASSAY TEST SYSTEM
2
Cleared 510(K)
K
78
2157
IRMA TEST, NORDICLAB FERRITIN
2
Cleared 510(K)
K
78
1946
RIA KIT, FERRITIN SOLID PHASE
2
Cleared 510(K)
K
78
1888
ASSAY SYSTEM, FERRITIN I KIT
2
Cleared 510(K)
K
78
1844
FERRITIN KIT
2
Cleared 510(K)
K
78
1527
RIA SYSTEM FOR HUMAN FE-RITIN
2
Cleared 510(K)
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
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 16 May 2025 at 11:05 pm
CH
/
subpart-f—immunological-test-systems
/
JMG
/
K781527
View Source
RIA SYSTEM FOR HUMAN FE-RITIN
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K781527
510(k) Type
Traditional
Applicant
CALBIOCHEM-BEHRING CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/3/1978
Days to Decision
28 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Miscellaneous
Subpart B—Biological Stains
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
Subpart D—Clinical Toxicology Test Systems
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Serological Reagents
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Immunological Test Systems
JMG
Radioimmunoassay (Two-Site Solid Phase), Ferritin
K
23
4052
Access Ferritin
K
05
2082
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
K
96
4282
TINA-QUANT FERRITIN ASSAY
K
97
1833
ELECSYS FERRITIN
K
96
3498
FERR FLEX REAGENT CARTRIDGE
K
95
0393
ACE(TM) CEDIA(R) FERRITIN ASSAY
K
92
6221
ACCESS FERRITIN ASSAY
K
92
5848
IMMULITE FERRITIN
K
92
0829
COBAS CORE FERRITIN EIA
K
92
0318
CEDIA FERRITIN ASSAY
K
90
2997
MILENIA (TM) FERRITIN
K
89
0697
RIA-GNOST FERRITIN
K
88
1138
CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.
K
87
3730
MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT
K
87
2955
DELFIA(TM) FERRITIN KIT
K
84
0460
CORNINGS MAGIC FERRITIN RADIOIMMUNO-
K
81
0799
QUANTIMUNE FERRITIN IRMA
K
79
2588
TERRITIN RIA KIT
K
79
1096
RADIOIMMUNOASSAY TEST SYSTEM
K
78
2157
IRMA TEST, NORDICLAB FERRITIN
K
78
1946
RIA KIT, FERRITIN SOLID PHASE
K
78
1888
ASSAY SYSTEM, FERRITIN I KIT
K
78
1844
FERRITIN KIT
K
78
1527
RIA SYSTEM FOR HUMAN FE-RITIN
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
CH
/
subpart-f—immunological-test-systems
/
JMG
/
K781527
View Source
RIA SYSTEM FOR HUMAN FE-RITIN
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K781527
510(k) Type
Traditional
Applicant
CALBIOCHEM-BEHRING CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/3/1978
Days to Decision
28 days