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510(k) K905485

IMMUNOWELL THYROGLOBULIN TEST by General Biometrics, Inc. — Product Code JZO

K905485 is an FDA 510(k) premarket notification submitted by General Biometrics, Inc. for the device "IMMUNOWELL THYROGLOBULIN TEST". The FDA issued a decision of Substantially Equivalent on January 25, 1991. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. General Biometrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1991
Date Received
December 6, 1990
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 General Biometrics, Inc.

  • K924843 — IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL (December 1, 1992)
  • K920401 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST (August 20, 1992)
  • K920400 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST (August 20, 1992)
  • K911627 — IMMUNODOT BORRELIA (LYME) TEST (April 8, 1992)
  • K911599 — IMMUNOWELL LYME (P39 RECOMBINANT) TEST (December 30, 1991)
  • K911590 — IMMUNOWELL BORRELIA (LYME)TEST (December 20, 1991)
  • K914801 — IMMUNOWELL DSDNA ANTIBODY TEST (December 9, 1991)
  • K911849 — IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST (May 7, 1991)
  • K911848 — IMMUNOWELL RNP/SM ANTIBODY TEST (May 7, 1991)
  • K911851 — IMMUNOWELL SM ANTIBODY TEST (May 7, 1991)

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