Home / 510(k) Clearances / K923370

510(k) K923370

AUTOSTAT ANTI-THYROGLOBULIN by Cogent Diagnotics , Ltd. — Product Code JNL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1992
Date Received
July 9, 1992
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 Cogent Diagnotics , Ltd.

  • K003057 — AUTOSTAT II ENA-4 PROFILE ELISA (October 13, 2000)
  • K003054 — AUTOSTAT II ENA-6 PROFILE ELISA (October 13, 2000)
  • K002215 — AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA (September 28, 2000)
  • K993557 — AUTOSTAT II RHEUMATOID FACTOR IGA ELISA (March 3, 2000)
  • K994338 — AUTOSTAT II RHEUMATOID FACTOR IGM ELISA (February 3, 2000)
  • K993085 — AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA (February 1, 2000)
  • K993304 — AUTOSTAT II RHEUMATOID FACTOR IGG ELISA (December 6, 1999)
  • K992449 — AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA (November 24, 1999)
  • K993086 — AUTOSTAT II ANTI-GLIADIN IGA ELISA (November 12, 1999)
  • K993087 — AUTOSTAT II ANTI-GLIADIN IGG ELISA (November 12, 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)