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510(k) K032134

TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT by Kronus Market Development Associates, Inc. — Product Code JZO

K032134 is an FDA 510(k) premarket notification submitted by Kronus Market Development Associates, Inc. for the device "TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT". The FDA issued a decision of Substantially Equivalent on September 10, 2003. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Kronus Market Development Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2003
Date Received
July 11, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Thyroid Autoantibody
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

Other clearances by Kronus Market Development Associates, Inc.

  • DEN140001 — ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT (August 20, 2014)
  • K121046 — STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT (December 20, 2012)
  • 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)
  • K073590 — KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT (April 10, 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)

Other clearances for product code JZO

  • K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II (October 17, 2025)
  • K240469 — Access TPO Antibody (August 9, 2024)
  • K213517 — Access Thyroglobulin Antibody II (September 26, 2023)
  • K222610 — Elecsys Anti-Tg (September 15, 2023)
  • K193313 — Elecsys Anti-TSHR (February 27, 2020)
  • K151799 — EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Contr (March 25, 2016)
  • K152061 — IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material (March 3, 2016)
  • K092229 — THYRETAIN TM TSI REPORTER BIOASSAY (May 18, 2010)
  • K090760 — THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-12 (September 3, 2009)
  • K083391 — THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (May 21, 2009)

FDA data resources