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510(k) K073590

KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT by Kronus Market Development Associates, Inc. — Product Code OIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2008
Date Received
December 20, 2007
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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  • K111956 — KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT (May 30, 2012)
  • K080523 — KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT (June 17, 2008)
  • K080159 — KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT (May 22, 2008)
  • K072135 — KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT (November 7, 2007)
  • K070183 — KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT (July 13, 2007)
  • K051061 — KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT (November 4, 2005)
  • K042248 — KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT (December 17, 2004)
  • K032134 — TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT (September 10, 2003)

Other clearances for product code OIF

  • K220085 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (August 24, 2023)
  • K171731 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (January 19, 2018)