Mda Heparin Anti-X Assay
FDA 510(k) K965076 · Organon Teknika Corp.
510(k) numberK965076
Submission
- Device name
- Mda Heparin Anti-X Assay
- Applicant
- Organon Teknika Corp.
Durham, NC, US - Received
- December 19, 1996
- Decision date
- March 18, 1997
- 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
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| K111822 | Sta(R) - Liquid Anti-Xa, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWHKFF · Traditional | Diagnostica Stago, Inc. | 10/26/2011SE |
| K090209 | Hemosil Liquid Heparin, Heparin Calibrators and LMW and Uf Heparin ControlsKFF · Traditional | Instrumentation Laboratory CO | 06/02/2009SE |
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| 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 |
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| K993423 | Bact/Alert SAMDB · Traditional | 12/15/1999SE |
| K993576 | Bact/Alert MP Process BottleMDB · Traditional | 12/14/1999SE |
| K993421 | Bact/Alert SNMDB · Traditional | 12/14/1999SE |
| K992432 | Bact/Alert FNMDB · Traditional | 09/24/1999SE |
| K983762 | Nuclisens CMV PP67LIN · Traditional | 09/15/1999SE |
| K992401 | Bact/Alert PFMDB · Traditional | 09/03/1999SE |
Questions and answers
When was Mda Heparin Anti-X Assay cleared by the FDA?
Mda Heparin Anti-X Assay (K965076) received a 510(k) decision of Substantially Equivalent on March 18, 1997, 89 days after the submission was received.
What is the product code of K965076?
The FDA product code is KFF – Assay, Heparin, a Class II (moderate risk) device regulated under 21 CFR 864.7525.