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510(k) Data Aggregation
K Number
K091468Device Name
IVD TECHNOLOGIES ACHRAB TEST KIT
Manufacturer
IVD TECHNOLOGIES
Date Cleared
2009-11-20
(186 days)
Product Code
NST
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
IVD TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AChRAb Assay is a radioimmunoassay for the in-vitro-diagnostic semiquantitative determination of autoantibodies against the acetylcholine receptor in human serum.
The AChRAb assay is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG) in conjunction with other clinical and laboratory findings.
Device Description
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