Home / 510(k) Clearances / K211485

510(k) K211485

STA- NeoPTimal by Diagnostica Stago S.A.S — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2022
Date Received
May 13, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

Other clearances by Diagnostica Stago S.A.S

  • K212183 — STA R Max 3, STA Compact Max 3 (June 7, 2023)
  • K162227 — STA® - Liatest® D-Di (December 10, 2016)
  • K151867 — STA R MAX (August 7, 2015)
  • K141144 — STA LIATEST D-DI (September 3, 2014)
  • K120014 — STA- COAG CONTROL (N+ABN) PLUS (March 14, 2013)
  • K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / (October 26, 2011)
  • K092937 — STA-HYBRID HEP CALIBRATOR (August 2, 2010)
  • K093167 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (December 22, 2009)
  • K092170 — STA LIATEST FREE PS (December 22, 2009)
  • K092113 — STA - FREE PS CALIBRATOR (November 13, 2009)

Other clearances for product code GJS

  • K253188 — CoaguChek XS Plus System (October 24, 2025)
  • K251564 — microINR System (July 21, 2025)
  • K243543 — microINR System (February 27, 2025)
  • K230802 — Xprecia Prime Coagulation System (March 15, 2024)
  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K231711 — microINR System (July 11, 2023)
  • K212779 — Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (October 5, 2022)
  • K213426 — HemosIL ReadiPlasTin (August 16, 2022)
  • K201185 — microINR System (December 18, 2020)
  • K183255 — Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (February 21, 2019)