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510(k) K910261

IMMULITE(TM) TOTAL T4 by Cirrus Diagnostics, Inc. — Product Code KLI

K910261 is an FDA 510(k) premarket notification submitted by Cirrus Diagnostics, Inc. for the device "IMMULITE(TM) TOTAL T4". The FDA issued a decision of Substantially Equivalent on April 16, 1991. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Cirrus Diagnostics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1991
Date Received
January 22, 1991
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 Cirrus Diagnostics, Inc.

  • K921704 — IMMULITE(R) FSH (June 9, 1992)
  • K920411 — IMMULITE HLH (March 11, 1992)
  • K914833 — IMMULITE DIGOXIN (November 22, 1991)
  • K911796 — IMMULITE(TM) HCG (June 20, 1991)
  • K910677 — IMMULITE(TM) T-UPTAKE (April 29, 1991)
  • K905648 — CRP LIPID REAGENT TEST PACK (March 6, 1991)
  • K905214 — IMMULITE (TM) TOTAL T3 (February 1, 1991)
  • K905769 — IMMULITE HS-TSH (January 31, 1991)
  • K905215 — IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER (January 11, 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