Home / 510(k) Clearances / K954256

510(k) K954256

ANTI-TPO by Biomerica, Inc. — Product Code JNL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1995
Date Received
September 5, 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 Biomerica, Inc.

  • K232892 — Hp Detect™ Stool Antigen ELISA (December 15, 2023)
  • K003856 — EZ-HCG URINE(PREGNANCY TEST) (February 21, 2001)
  • K982954 — FREE T4 MICROWELL EIA, MODEL #7019 (September 24, 1998)
  • K962216 — TSH (MICROWELL) ELISA (September 19, 1996)
  • K960412 — T-3 MICROWELL EIA MODEL 7013 (March 19, 1996)
  • K950588 — T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 (June 29, 1995)
  • K936010 — THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY (July 18, 1994)
  • K915185 — GAP IGG H.PYLORI MODIFIED (March 4, 1992)
  • K900343 — GAP-IGG (August 22, 1991)

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)
  • K951364 — MICROSOMAL EIA TEST KIT (November 20, 1995)
  • K951362 — THYROGLOBULIN EIA TEST KIT (November 20, 1995)