Sta(R) - Liquid Anti-Xa, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWH
FDA 510(k) K111822 · Diagnostica Stago, Inc.
510(k) numberK111822
Submission
- Device name
- Sta(R) - Liquid Anti-Xa, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWH
- Applicant
- Diagnostica Stago, Inc.
Rome, IT - Received
- June 28, 2011
- Decision date
- October 26, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KFF – Assay, Heparin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7525
- Specialty
- Hematology
Other 510(k)s with product code KFF
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|---|---|---|---|
| K213464 | HemosIL Liquid Anti-XaKFF · Special | Instrumentation Laboratory CO | 10/04/2022SE |
| K162540 | INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF…KFF · Traditional | Siemens Healthcare Diagnostics Prodcts GmbH | 08/22/2017SE |
| K090209 | Hemosil Liquid Heparin, Heparin Calibrators and LMW and Uf Heparin ControlsKFF · Traditional | Instrumentation Laboratory CO | 06/02/2009SE |
| K050367 | Biophen Heparin 3, Biophen Heparin 6KFF · Traditional | Hyphen Biomed | 05/24/2006SE |
| K013305 | Enoxaparin Test CardKFF · Traditional | Cardiovascular Diagnostics, Inc. | 08/23/2002SE |
| K013637 | Actichrome Heparin (Anti-Fiia)KFF · Traditional | American Diagnostica, Inc. | 04/16/2002SE |
| K013318 | Actichrome Heparin (Anti-Fxa), Model 832KFF · Traditional | American Diagnostica, Inc. | 03/08/2002SE |
| K010455 | Rotachrom Heparin and Sta -Rotachrom HeparinKFF · Traditional | Diagnostica-Stago | 06/07/2001SE |
| K010193 | Hemochron Kaolin-Activated Heparin and Protamine Dosing AssaysKFF · Traditional | International Technidyne Corp. | 06/06/2001SE |
| K983178 | Coamatic HeparinKFF · Traditional | Instrumentation Laboratory CO | 11/03/1998SE |
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| K141144 | Sta Liatest D-DiDAP · Traditional | 09/03/2014SE |
| K120014 | Sta- Coag Control (N+Abn) PlusGGN · Traditional | 03/14/2013SE |
| K130090 | Sta Compact MaxJPA · Special | 02/12/2013SE |
| K092937 | Sta-Hybrid Hep CalibratorJIT · Traditional | 08/02/2010SE |
| K093167 | Sta Compact Automated Multi-Parametric AnalyzerJPA · Special | 12/22/2009SE |
| K092170 | Sta Liatest Free PSGGP · Special | 12/22/2009SE |
| K093001 | Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric AnalyzerJPA · Special | 12/18/2009SE |
| K092113 | Sta - Free PS CalibratorJIX · Traditional | 11/13/2009SE |
Questions and answers
When was Sta(R) - Liquid Anti-Xa, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWH cleared by the FDA?
Sta(R) - Liquid Anti-Xa, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWH (K111822) received a 510(k) decision of Substantially Equivalent on October 26, 2011, 120 days after the submission was received.
What is the product code of K111822?
The FDA product code is KFF – Assay, Heparin, a Class II (moderate risk) device regulated under 21 CFR 864.7525.