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510(k) K111822

STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH by Diagnostica Stago, Inc. — Product Code KFF

K111822 is an FDA 510(k) premarket notification submitted by Diagnostica Stago, Inc. for the device "STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH". The FDA issued a decision of Substantially Equivalent on October 26, 2011. The device falls under product code KFF (Assay, Heparin), a Class II device regulated under 21 CFR 864.7525. Diagnostica Stago, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2011
Date Received
June 28, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Heparin
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type

Other clearances by Diagnostica Stago, Inc.

  • K253658 — STA Satellite Max® (April 27, 2026)
  • K212183 — STA R Max 3, STA Compact Max 3 (June 7, 2023)
  • K211485 — STA- NeoPTimal (December 23, 2022)
  • 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)
  • 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)

Other clearances for product code KFF

  • K213464 — HemosIL Liquid Anti-Xa (October 4, 2022)
  • K162540 — INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Hep (August 22, 2017)
  • K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS (June 2, 2009)
  • K050367 — BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 (May 24, 2006)
  • K013305 — ENOXAPARIN TEST CARD (August 23, 2002)
  • K013637 — ACTICHROME HEPARIN (ANTI-FIIA) (April 16, 2002)
  • K013318 — ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 (March 8, 2002)
  • K010455 — ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN (June 7, 2001)
  • K010193 — HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS (June 6, 2001)
  • K983178 — COAMATIC HEPARIN (November 3, 1998)

FDA data resources