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510(k) K840241

THYROXINE EMIA by Collaborative Research, Inc. — Product Code KLI

K840241 is an FDA 510(k) premarket notification submitted by Collaborative Research, Inc. for the device "THYROXINE EMIA". The FDA issued a decision of Substantially Equivalent on March 30, 1984. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Collaborative Research, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1984
Date Received
January 20, 1984
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 Collaborative Research, Inc.

  • K841541 — SERUM COMPLEMENT ACTIVITY TEST-SCAT (June 1, 1984)

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