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510(k) K950588

T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 by Biomerica, Inc. — Product Code KLI

K950588 is an FDA 510(k) premarket notification submitted by Biomerica, Inc. for the device "T4 MICROWELL EIA (ENZYME IMMUNOASSAY0". The FDA issued a decision of Substantially Equivalent on June 29, 1995. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Biomerica, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1995
Date Received
February 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
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)
  • K954256 — ANTI-TPO (November 27, 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 KLI

  • K160495 — VITROS® Automation Solutions (October 18, 2016)
  • K131515 — ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT (August 14, 2013)
  • K103484 — GSP NEONATAL THYROXINE (T4) (April 22, 2011)
  • K082638 — ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL (February 26, 2009)
  • K030860 — ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (August 22, 2003)
  • K023369 — ACCESS TOTAL T4 ASSAY (December 9, 2002)
  • K001603 — REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) (October 5, 2000)
  • K000600 — SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS (March 27, 2000)
  • K991432 — BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 (June 2, 1999)
  • K982298 — OPTICOAT T4 EIA KIT (February 3, 1999)

FDA data resources