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510(k) K971709

TOTAL THROXINE MICROPLATE EIA(225-300) by Monobind — Product Code KLI

K971709 is an FDA 510(k) premarket notification submitted by Monobind for the device "TOTAL THROXINE MICROPLATE EIA(225-300)". The FDA issued a decision of Substantially Equivalent on June 16, 1997. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Monobind has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1997
Date Received
May 8, 1997
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 Monobind

  • K181017 — Free Testosterone AccuBind ELISA Test System (July 20, 2018)
  • K063437 — ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 (April 4, 2008)
  • K030860 — ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (August 22, 2003)
  • K020548 — FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 (April 5, 2002)
  • K980088 — T-UPTAKE MICROPLATE EIA (February 4, 1998)
  • K972720 — FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) (September 2, 1997)
  • K971834 — ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (July 3, 1997)
  • K971835 — ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA (July 3, 1997)
  • K971921 — PROLACTIN (PRL) HORMONE MICROPLATE ELISA (June 24, 1997)
  • K971780 — THYROTROPIN(TSH) ELISA (June 24, 1997)

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