Home / 510(k) Clearances / K896982

510(k) K896982

AIA-PACK T4 by Tosoh Corp. — Product Code KLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1990
Date Received
December 19, 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 Tosoh Corp.

  • K023239 — AIA-PACK CA 19-9 (December 23, 2002)
  • K023240 — ST AIA-PACK CA 19-9 (December 23, 2002)
  • K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (July 21, 1992)
  • K913663 — AIA-PACK T-U (September 30, 1991)
  • K913298 — AIA-PACK CK-MB (September 27, 1991)
  • K913493 — AIA-PACK FT4 (September 10, 1991)
  • K903628 — AIA-PACK IRI (September 7, 1990)
  • K901965 — MPR-4A - MICRO-PLATE READER (May 10, 1990)
  • K901674 — AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM (May 2, 1990)
  • K897001 — TOSOH AIA-PACK T3 (March 9, 1990)

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)