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510(k) K885258

ACA THYROXINE (T4 E) METHOD by The DU Pont Co. — Product Code KLI

K885258 is an FDA 510(k) premarket notification submitted by The DU Pont Co. for the device "ACA THYROXINE (T4 E) METHOD". The FDA issued a decision of Substantially Equivalent on February 17, 1989. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. The DU Pont Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1989
Date Received
December 23, 1988
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 The DU Pont Co.

  • K953475 — CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING (October 7, 1995)
  • K953477 — MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING (October 7, 1995)
  • K952891 — CRONEX LOW ABSORPTION CASSETTE (July 13, 1995)
  • K945125 — DUPONT ACA VANCOMYCIN (VANC) METHOD (March 10, 1995)
  • K943704 — LIPASE CALIBRATOR (September 14, 1994)
  • K900492 — LABELING CHANGE - VIASPAN(TM) (BELZER UW) (March 20, 1990)
  • K885259 — ACA THYRONINE UPTAKE (TU E) METHOD (February 17, 1989)
  • K884700 — ANALYST THYROXINE (T4) ROTOR (January 27, 1989)
  • K884169 — DU PONT ANALYST THYROID ROTOR (January 24, 1989)
  • K884168 — ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. (November 29, 1988)

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