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Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
2
Product Code
K
21
3776
LiverSmart
2
Cleared 510(K)
Show All 3 Submissions
General and Plastic Surgery
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Last synced on 19 July 2024 at 11:05 pm
RA
/
RA-misc
/
PCS
/
K213776
View Source
LiverSmart
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213776
510(k) Type
Special
Applicant
Resonance Health Analysis Services Pty Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
12/29/2021
Days to Decision
27 days
Submission Type
Summary
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
Miscellaneous
PCS
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
K
21
3776
LiverSmart
Show All 3 Submissions
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
RA
/
RA-misc
/
PCS
/
K213776
View Source
LiverSmart
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213776
510(k) Type
Special
Applicant
Resonance Health Analysis Services Pty Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
12/29/2021
Days to Decision
27 days
Submission Type
Summary