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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
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Dental
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Ear, Nose, Throat
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Gastroenterology and Urology
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General Hospital
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Hematology
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Miscellaneous
Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cell And Tissue Culture Products
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart E—Specimen Preparation Reagents
CFR Sub-Part
Subpart F—Automated and Semi-Automated Hematology Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
DBT
Factor Xiii A, S, Antigen, Antiserum, Control
1
Product Code
DDE
Carbonic Anhydrase C, Antigen, Antiserum, Control
1
Product Code
DDF
Prothrombin, Antigen, Antiserum, Control
1
Product Code
DDH
Carbonic Anhydrase B, Antigen, Antiserum, Control
1
Product Code
DDX
Plasminogen, Antigen, Antiserum, Control
1
Product Code
DGB
Seminal Fluid, Antigen, Antiserum, Control
1
Product Code
DGQ
Whole Blood Plasma, Antigen, Antiserum, Control
1
Product Code
DGR
Whole Human Serum, Antigen, Antiserum, Control
1
Product Code
K
96
1544
QUALITROL IGAME CONTROLS, LEVELS 1 AND 2
1
Cleared 510(K)
K
90
2220
PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
1
Cleared 510(K)
K
86
5014
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II
1
Cleared 510(K)
K
79
0298
RADIOASSAY, CONTROL SERUM I, II, III
1
Cleared 510(K)
K
78
1355
ICS NORMAL CONTROL SERUM
1
Cleared 510(K)
KTK
Reagent, Immunoassay, Carbonic Anhydrase B And C
1
Product Code
MVS
Kit, Typing, Hla-Dqb
2
Product Code
Subpart G—Manual Hematology Devices
CFR Sub-Part
Subpart G—Tumor Associated Antigen immunological Test Systems
CFR Sub-Part
Subpart H—Hematology Kits and Packages
CFR Sub-Part
Subpart I—Hematology Reagents
CFR Sub-Part
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
CFR Sub-Part
Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
CFR Sub-Part
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 9 May 2025 at 11:05 pm
HE
/
subpart-f—immunological-test-systems
/
DGR
/
K865014
View Source
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K865014
510(k) Type
Traditional
Applicant
BIO-RAD
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/9/1987
Days to Decision
17 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Miscellaneous
Subpart B—Biological Stains
Subpart B—Diagnostic Devices
Subpart C—Cell And Tissue Culture Products
Subpart C—Clinical Laboratory Instruments
Subpart E—Specimen Preparation Reagents
Subpart F—Automated and Semi-Automated Hematology Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Immunological Test Systems
DBT
Factor Xiii A, S, Antigen, Antiserum, Control
DDE
Carbonic Anhydrase C, Antigen, Antiserum, Control
DDF
Prothrombin, Antigen, Antiserum, Control
DDH
Carbonic Anhydrase B, Antigen, Antiserum, Control
DDX
Plasminogen, Antigen, Antiserum, Control
DGB
Seminal Fluid, Antigen, Antiserum, Control
DGQ
Whole Blood Plasma, Antigen, Antiserum, Control
DGR
Whole Human Serum, Antigen, Antiserum, Control
K
96
1544
QUALITROL IGAME CONTROLS, LEVELS 1 AND 2
K
90
2220
PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
K
86
5014
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II
K
79
0298
RADIOASSAY, CONTROL SERUM I, II, III
K
78
1355
ICS NORMAL CONTROL SERUM
KTK
Reagent, Immunoassay, Carbonic Anhydrase B And C
MVS
Kit, Typing, Hla-Dqb
Subpart G—Manual Hematology Devices
Subpart G—Tumor Associated Antigen immunological Test Systems
Subpart H—Hematology Kits and Packages
Subpart I—Hematology Reagents
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HE
/
subpart-f—immunological-test-systems
/
DGR
/
K865014
View Source
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K865014
510(k) Type
Traditional
Applicant
BIO-RAD
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/9/1987
Days to Decision
17 days