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Found 2 results

510(k) Data Aggregation

K Number

Device Name

KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT

Manufacturer

KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.

Date Cleared

2007-11-07

(97 days)

Product Code

NWG

Regulation Number

866.5660

Why did this record match?

Product Code :

NWG

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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K Number

Device Name

KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT

Manufacturer

KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.

Date Cleared

2005-11-04

(192 days)

Product Code

NWG

Regulation Number

866.5660

Why did this record match?

Product Code :

NWG

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The KRONUS GADAb RIA Assay Kit is for the semi-quantitative determination of glutamic acid decarboxylase antibody in human serum. The KRONUS GADAb RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).

Device Description

KRONUS Glutamic Acid Decarboxylase (GADAb) RIA Assay Kit

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