Home / 510(k) Clearances / K160541

510(k) K160541

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control by Sysmex America, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2016
Date Received
February 26, 2016
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 Sysmex America, Inc.

  • K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer (June 25, 2025)
  • K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer (June 25, 2025)
  • K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000) (June 2, 2025)
  • K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (December 21, 2023)
  • K210346 — Sysmex XW-100 Automated Hematology Analyzer (November 8, 2022)
  • K182389 — Sysmex XN-L Automated Hematology Analyzer (January 25, 2019)
  • K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (October 30, 2018)
  • K171883 — Sysmex UF-5000 Fully Automated Urine Particle Analyzer (April 23, 2018)
  • K172604 — XW-100 Automated Hematology Analyzer for CLIA Waived Use (November 6, 2017)
  • K160538 — Sysmex XN-L Automated Hematology Analyzer (December 22, 2016)

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)