Coatest LMW Heparin/Heparin Chromogenic Assay
FDA 510(k) K901874 · Kabi Diagnostica
510(k) numberK901874
Submission
- Device name
- Coatest LMW Heparin/Heparin Chromogenic Assay
- Applicant
- Kabi Diagnostica
Danville, CA, US - Received
- April 26, 1990
- Decision date
- July 20, 1990
- 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
Other 510(k)s with product code KFF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
More from International Technidyne Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K902393 | Coacute Antithrombin Chromogenic AssayJBQ · Traditional | 09/25/1990SE |
Questions and answers
When was Coatest LMW Heparin/Heparin Chromogenic Assay cleared by the FDA?
Coatest LMW Heparin/Heparin Chromogenic Assay (K901874) received a 510(k) decision of Substantially Equivalent on July 20, 1990, 85 days after the submission was received.
What is the product code of K901874?
The FDA product code is KFF – Assay, Heparin, a Class II (moderate risk) device regulated under 21 CFR 864.7525.