Coatest Heparin
FDA 510(k) K833891 · Kabivitrum, Inc.
510(k) numberK833891
Submission
- Device name
- Coatest Heparin
- Applicant
- Kabivitrum, Inc.
Mchenry, IL, US - Received
- November 9, 1983
- Decision date
- January 30, 1984
- 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 |
|---|---|---|
| K884058 | Coatest Protein CGGP · Traditional | 12/13/1988SE |
| K854572 | Coatest PlasminogenDDX · Traditional | 02/26/1986SE |
| K844664 | The I.V. BagKPE · Traditional | 05/06/1985SE |
| K833892 | Coatest Factor ViiiGGP · Traditional | 01/30/1984SE |
| K833890 | Coatest AntiplasminLGP · Traditional | 01/30/1984SE |
| K832114 | Coatest Factor XGGP · Traditional | 08/26/1983SE |
| K812829 | Coatest AntithrombinJBQ · Traditional | 12/30/1981SE |
Questions and answers
When was Coatest Heparin cleared by the FDA?
Coatest Heparin (K833891) received a 510(k) decision of Substantially Equivalent on January 30, 1984, 82 days after the submission was received.
What is the product code of K833891?
The FDA product code is KFF – Assay, Heparin, a Class II (moderate risk) device regulated under 21 CFR 864.7525.