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510(k) K984228

IS ANTI-TPO IGG ELISA TEST SYSTEM by Columbia Bioscience, Inc. — Product Code JZO

K984228 is an FDA 510(k) premarket notification submitted by Columbia Bioscience, Inc. for the device "IS ANTI-TPO IGG ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on February 2, 1999. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Columbia Bioscience, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1999
Date Received
November 25, 1998
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 Columbia Bioscience, Inc.

  • K990462 — IS H. PYLORI IGG ELISA TEST SYSTEM (September 3, 1999)
  • K991274 — MUMPS IGG ELISA TEST SYSTEM (September 3, 1999)
  • K983606 — IS BORRELIA BURGDORFERI IGM TEST SYSTEM (December 16, 1998)
  • K983605 — IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (December 16, 1998)
  • K983553 — ANTI-TG IGG ELISA TEST SYSTEM (December 7, 1998)
  • K982348 — EBNA-1 IGM ELISA TEST SYSTEM (November 25, 1998)
  • K982350 — EA-D IGM ELISA TEST SYSTEM (November 25, 1998)
  • K982352 — VCA IGM ELISA TEST SYSTEM (November 25, 1998)
  • K983390 — IS-ANTI-MPO IGG ELISA TEST SYSTEM (November 18, 1998)
  • K983740 — IS-ANTI-PR3 IGG ELISA TEST SYSTEM (November 18, 1998)

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