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510(k) K896865

VITRO T4-EIA-XT by In Vitro Diagnostics, Inc. — Product Code KLI

K896865 is an FDA 510(k) premarket notification submitted by In Vitro Diagnostics, Inc. for the device "VITRO T4-EIA-XT". The FDA issued a decision of Substantially Equivalent on January 30, 1990. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. In Vitro Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1990
Date Received
December 6, 1989
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 In Vitro Diagnostics, Inc.

  • K896867 — THYROID STIMULATING HORMONE-EIA-XT (February 23, 1990)
  • K896863 — DIGOXIN-EIA-XT (February 13, 1990)
  • K896866 — LUTEINIZING HORMONE-EIA-XT (February 13, 1990)
  • K896925 — T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT (January 18, 1990)
  • K896864 — FOLLICLE STIMULATING HORMONE-EIA-XT (January 11, 1990)
  • K873832 — REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 (November 23, 1987)
  • K871185 — LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 (May 28, 1987)
  • K871183 — FLAME PHOTOMETER STANDARD #60082 140 NA/5K (May 28, 1987)
  • K871186 — CESIUM DILUENT 1.5 MMOL CS/L #60087 (May 28, 1987)
  • K871188 — LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 (May 28, 1987)

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