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510(k) K072135

KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT by Kronus Market Development Associates, Inc. — Product Code NWG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2007
Date Received
August 2, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Autoantibodies, Glutamic Acid Decarboxylase (Gad)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).

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Other clearances for product code NWG

  • K051061 — KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT (November 4, 2005)