Heparin Controls, High and Low
FDA 510(k) K910741 · Sigma Diagnostics, Inc.
510(k) numberK910741
Submission
- Device name
- Heparin Controls, High and Low
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- February 21, 1991
- Decision date
- April 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KFF – Assay, Heparin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7525
- Specialty
- Hematology
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| K162540 | INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF…KFF · Traditional | Siemens Healthcare Diagnostics Prodcts GmbH | 08/22/2017SE |
| 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 |
| 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 |
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| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
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| K010158 | Thrombomax-Hs with Calcium, Model T6540GGO · Traditional | 03/22/2001SE |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | 03/01/2001SE |
Questions and answers
When was Heparin Controls, High and Low cleared by the FDA?
Heparin Controls, High and Low (K910741) received a 510(k) decision of Substantially Equivalent on April 29, 1991, 67 days after the submission was received.
What is the product code of K910741?
The FDA product code is KFF – Assay, Heparin, a Class II (moderate risk) device regulated under 21 CFR 864.7525.