Kronus Glutamic Acid Decarboxylase Antibody Kit

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K051061 ↗

FDA Product Code

NWG

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K073590 Active Cleared 10 Apr 2008

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  FDA 510(k) K070183 Active Cleared 13 Jul 2007

• Kronus Gad Autoantibody Elisa Assay Kit

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• Tsh Receptor Antibody (Trab) Coated Tube (CT) Assay Kit

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• Kronus Voltage Gated Calcium Channel (Vgcc) Antibody Ria Assay Kit

  Class II

  FDA 510(k) K111956 Active Cleared 30 May 2012

• Zinc Transporter 8 Antibody (ZNT8AB) Elisa Assay Kit

  Class II

  FDA De Novo DEN140001 Active Cleared 20 Aug 2014 FDA 510(k)

See all devices from Kronus Market Development Associates, Inc. →