Home / 510(k) Clearances / K843281

510(k) K843281

ACCUSCREEN TSH by Neometrics, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1984
Date Received
August 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
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 JLW

  • K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII) (February 6, 2026)
  • K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimens (April 25, 2025)
  • K234091 — Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 (July 22, 2024)
  • K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII) (April 4, 2024)
  • K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL (July 13, 2023)
  • K221225 — Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer (November 10, 2022)
  • K190773 — Elecsys TSH (April 16, 2019)
  • K170232 — AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer (October 13, 2017)
  • K171103 — Lumipulse G TSH-III Immunoreaction Cartridges (July 28, 2017)
  • K162698 — MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer (July 14, 2017)