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510(k) K171731

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit by Kronus, Inc. — Product Code OIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2018
Date Received
June 12, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tyrosine Phosphatase (Ia-2) Autoantibody Assay
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).

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  • K915429 — KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT (March 30, 1992)
  • K915428 — KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT (March 30, 1992)
  • K894364 — MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) (July 25, 1989)
  • K894203 — ANTI-THYROGLOBULIN TEST KIT (July 25, 1989)

Other clearances for product code OIF

  • K220085 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (August 24, 2023)
  • K073590 — KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT (April 10, 2008)