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510(k) K033454

BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN by Brahms Diagnostica, LLC — Product Code JZO

K033454 is an FDA 510(k) premarket notification submitted by Brahms Diagnostica, LLC for the device "BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN". The FDA issued a decision of Substantially Equivalent on March 22, 2004. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Brahms Diagnostica, LLC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2004
Date Received
October 30, 2003
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 Brahms Diagnostica, LLC

  • K021057 — BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS (September 17, 2002)
  • K000286 — BRAHMS DIAGNOSTICA LUMITEST ANTI-TG (March 17, 2000)
  • K000287 — BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO (March 17, 2000)
  • K992790 — BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG (November 12, 1999)
  • K992791 — BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO (November 12, 1999)

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