Home / 510(k) Clearances / K142021

510(k) K142021

Elecsys Estradiol III CalSet by Roche Diagnostics — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2014
Date Received
July 25, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Roche Diagnostics

  • K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (February 12, 2026)
  • K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; (February 12, 2026)
  • K253839 — Elecsys Anti-SARS-CoV-2 (December 17, 2025)
  • K253188 — CoaguChek XS Plus System (October 24, 2025)
  • K252163 — Elecsys Phospho-Tau (181P) Plasma (October 8, 2025)
  • K242505 — Elecsys Cortisol III (July 17, 2025)
  • K250768 — Elecsys Anti-SARS-CoV-2 (June 10, 2025)
  • K241453 — Elecsys sFlt-1 and Elecsys PlGF (February 7, 2025)
  • K233060 — Elecsys Folate III (June 17, 2024)
  • K220272 — cobas pulse blood glucose monitoring system (April 26, 2024)

Other clearances for product code JIT

  • K171168 — VITROS Immunodiagnostic Products Insulin Calibrators (May 16, 2017)
  • K170938 — CalSet IGF-1 (April 26, 2017)
  • K170160 — Abbott ARCHITECT Free T3 (February 15, 2017)
  • K163534 — Lumipulse G FSH-N Calibrators (January 13, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (December 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (November 17, 2016)