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Innolitics
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Miscellaneous
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
LTB
Cyclosporine Radioimmunoassay
2
Product Code
MAR
Cyclosporine And Metabolites Serum Assay
2
Product Code
MGS
High Performance Liquid Chromatography For Cyclosporine
2
Product Code
MGU
Fluorescence Polarization Immunoassay For Cyclosporine
2
Product Code
MGV
Radioimmunoassay For Cyclosporine
2
Product Code
MKW
Cyclosporine
2
Product Code
K
08
0751
ARCHITECT CYCLOSPORINE
2
Cleared 510(K)
K
07
1455
ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
2
Cleared 510(K)
K
08
1992
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
2
Cleared 510(K)
K
06
2236
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
2
Cleared 510(K)
K
05
3061
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
2
Cleared 510(K)
K
05
2017
CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
2
Cleared 510(K)
K
04
0761
AXSYM CYCLOSPORINE
2
Cleared 510(K)
K
02
3208
CEDIA CYCLOSPORINE PLUS ASSAY
2
Cleared 510(K)
K
02
3065
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
2
Cleared 510(K)
P
92
0031
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
APRL
PMA Approval
MLM
Enzyme Immunoassay, Tracrolimus
2
Product Code
NFX
Test, Cholesterol, Total, Over The Counter
1
Product Code
NFZ
Test, Creatinine, Over The Counter
2
Product Code
NGA
Test, Follicle Stimulating Hormone (Fsh), Over The Counter
1
Product Code
NGD
Test, Lactic Acid, Over The Counter
1
Product Code
NGE
Test, Luteinizing Hormone (Lh), Over The Counter
1
Product Code
NGJ
Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
1
Product Code
NGO
Test, Triglycerides, Over The Counter
1
Product Code
PQO
Anti-Müllerian Hormone Test System
2
Product Code
QKE
Immunoassay, Pregnanediol Glucuronide, Over The Counter
1
Product Code
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart D—Clinical Toxicology Test Systems
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Subpart G—Manual Hematology Devices
CFR Sub-Part
Subpart H—Hematology Kits and Packages
CFR Sub-Part
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 25 January 2026 at 3:41 am
TX
/
subpart-b—clinical-chemistry-test-systems
/
MKW
/
K080751
View Source
ARCHITECT CYCLOSPORINE
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
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FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
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
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
LTB
Cyclosporine Radioimmunoassay
MAR
Cyclosporine And Metabolites Serum Assay
MGS
High Performance Liquid Chromatography For Cyclosporine
MGU
Fluorescence Polarization Immunoassay For Cyclosporine
MGV
Radioimmunoassay For Cyclosporine
MKW
Cyclosporine
K
08
0751
ARCHITECT CYCLOSPORINE
K
07
1455
ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
K
08
1992
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
K
06
2236
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
K
05
3061
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
K
05
2017
CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
K
04
0761
AXSYM CYCLOSPORINE
K
02
3208
CEDIA CYCLOSPORINE PLUS ASSAY
K
02
3065
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
P
92
0031
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
MLM
Enzyme Immunoassay, Tracrolimus
NFX
Test, Cholesterol, Total, Over The Counter
NFZ
Test, Creatinine, Over The Counter
NGA
Test, Follicle Stimulating Hormone (Fsh), Over The Counter
NGD
Test, Lactic Acid, Over The Counter
NGE
Test, Luteinizing Hormone (Lh), Over The Counter
NGJ
Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
NGO
Test, Triglycerides, Over The Counter
PQO
Anti-Müllerian Hormone Test System
QKE
Immunoassay, Pregnanediol Glucuronide, Over The Counter
Subpart C—Clinical Laboratory Instruments
Subpart D—Clinical Toxicology Test Systems
Subpart F—Immunological Test Systems
Subpart G—Manual Hematology Devices
Subpart H—Hematology Kits and Packages
Medical Genetics
Unknown
TX
/
subpart-b—clinical-chemistry-test-systems
/
MKW
/
K080751
View Source
ARCHITECT CYCLOSPORINE
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
Loading...