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510(k) K951320

AURAFLEX TG-AB AND TPO-AB by Organon Teknika Corp. — Product Code JNL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1995
Date Received
March 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunochemical, Thyroglobulin Autoantibody
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

Other clearances by Organon Teknika Corp.

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  • K994343 — BACT/ALERT SV (February 10, 2000)
  • K993423 — BACT/ALERT SA (December 15, 1999)
  • K993421 — BACT/ALERT SN (December 14, 1999)
  • K993576 — BACT/ALERT MP PROCESS BOTTLE (December 14, 1999)
  • K992432 — BACT/ALERT FN (September 24, 1999)
  • K983762 — NUCLISENS CMV PP67 (September 15, 1999)
  • K992401 — BACT/ALERT PF (September 3, 1999)

Other clearances for product code JNL

  • K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII) (December 4, 2025)
  • K240996 — Access Thyroglobulin Antibody II (July 3, 2024)
  • K112933 — ACCESS THYROGLOBULIN ANITBODY (December 27, 2011)
  • K072661 — IMMUNOCAP THYRLOBULIN IMMUNOCAP (November 20, 2007)
  • K062516 — ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALI (October 5, 2006)
  • K971834 — ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (July 3, 1997)
  • K962341 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) (November 25, 1996)
  • K962451 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) (November 25, 1996)
  • K954256 — ANTI-TPO (November 27, 1995)
  • K951362 — THYROGLOBULIN EIA TEST KIT (November 20, 1995)