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Found 3 results
510(k) Data Aggregation
K Number
K983132Device Name
IGM
Manufacturer
ABBOTT LABORATORIES
Date Cleared
1998-11-04
(57 days)
Product Code
DFT
Regulation Number
866.5550Why did this record match?
Product Code :
DFT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962201Device Name
QUANTEX IGM
Manufacturer
INSTRUMENTATION LABORATORY CO.
Date Cleared
1996-09-25
(110 days)
Product Code
DFT
Regulation Number
866.5550Why did this record match?
Product Code :
DFT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product permits the quantitative in vitro diagnostic determination of Immunoglobulin M in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Device Description
quantex IgM: 8 x 6 mL anti-human IgM P/N 3000-22135; 2 x 100 mL Buffer P/N 3000-22130
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K Number
K955797Device Name
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
Manufacturer
RANDOX LABORATORIES, LTD.
Date Cleared
1996-04-05
(105 days)
Product Code
DFT
Regulation Number
866.5550Why did this record match?
Product Code :
DFT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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