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Innolitics
Anesthesiology
Review Panel
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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—Clinical Chemistry Test Systems
CFR Sub-Part
MJX
Kit, Serological, Positive Control
1
Product Code
MJY
Kit, Serological, Negative Control
1
Product Code
MJZ
Kit, Direct Antigen, Positive Control
1
Product Code
K
08
3744
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
1
Cleared 510(K)
K
97
2182
ABBOTT STREP A CONTROLS
1
Cleared 510(K)
K
97
2129
CHLAMYDIATROL AG
1
Cleared 510(K)
MKA
Kit, Direct Antigen, Negative Control
1
Product Code
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart C—Microbiology Devices
CFR Sub-Part
Subpart D—Serological Reagents
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
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 25 January 2026 at 3:41 am
MI
/
subpart-b—clinical-chemistry-test-systems
/
MJZ
/
K972129
View Source
CHLAMYDIATROL AG
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
Loading...
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Miscellaneous
Subpart B—Biological Stains
Subpart B—Clinical Chemistry Test Systems
MJX
Kit, Serological, Positive Control
MJY
Kit, Serological, Negative Control
MJZ
Kit, Direct Antigen, Positive Control
K
08
3744
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
K
97
2182
ABBOTT STREP A CONTROLS
K
97
2129
CHLAMYDIATROL AG
MKA
Kit, Direct Antigen, Negative Control
Subpart B—Diagnostic Devices
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
Subpart D—Serological Reagents
Subpart F—Immunological Test Systems
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
MI
/
subpart-b—clinical-chemistry-test-systems
/
MJZ
/
K972129
View Source
CHLAMYDIATROL AG
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
Loading...