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510(k) K972974

ACCUWELL T4-EIA by Neometrics, Inc. — Product Code KLI

K972974 is an FDA 510(k) premarket notification submitted by Neometrics, Inc. for the device "ACCUWELL T4-EIA". The FDA issued a decision of Substantially Equivalent on October 6, 1997. The device falls under product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Neometrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1997
Date Received
August 11, 1997
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 Neometrics, Inc.

  • K152560 — Bard Snare Retrieval Kit (October 23, 2015)
  • K150225 — NovaGold High Performance Guidewire (March 16, 2015)
  • K143135 — Spring Coil Guidewire (February 20, 2015)
  • K133076 — NOVAGOLD HIGH PERFORMANCE GUIDEWIRE (February 20, 2014)
  • K123439 — NEO ERCP GUIDEWIRE (January 3, 2013)
  • K101729 — NEOWIRE PTA/PTCA GUIDEWIRE (September 23, 2010)
  • K070150 — VASCUPUNCTURE PICC GUIDEWIRE (February 15, 2007)
  • K043398 — MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE (March 1, 2005)
  • K040786 — VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING (April 19, 2004)
  • K033321 — SELECTIVA SB GUIDEWIRE (November 5, 2003)

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