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510(k) K103484

GSP NEONATAL THYROXINE (T4) by Wallac Oy, A Subsidiary of Perkinelmer, Inc. — Product Code KLI

K103484 is an FDA 510(k) premarket notification submitted by Wallac Oy, A Subsidiary of Perkinelmer, Inc. for the device "GSP NEONATAL THYROXINE (T4)". The FDA issued a decision of Substantially Equivalent on April 22, 2011. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Wallac Oy, A Subsidiary of Perkinelmer, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2011
Date Received
November 26, 2010
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 Wallac Oy, A Subsidiary of Perkinelmer, Inc.

  • K173829 — NeoLSD MSMS kit (July 18, 2018)
  • K133652 — GSP NEONATAL TOTAL GALACTOSE KIT (April 28, 2014)
  • K110274 — AUTODELFIA NEONATAL IRT KIT (June 10, 2011)

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)
  • 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)
  • K983440 — ABBOTT ARCHITECT TOTAL T4 (November 25, 1998)

FDA data resources