Heparin Assay
FDA 510(k) K781479 · Dade, Baxter Travenol Diagnostics, Inc.
510(k) numberK781479
Submission
- Device name
- Heparin Assay
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
Mchenry, IL, US - Received
- August 28, 1978
- Decision date
- February 15, 1979
- 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 |
|---|---|---|
| K800296 | Whole Blood Gas Control, Levels 1,2,&3GGM · Traditional | 03/05/1980SE |
| K792606 | Whole Blood Platelet Control Normal,JPK · Traditional | 02/13/1980SE |
| K792723 | Blood Fluid FiltersJKA · Traditional | 01/21/1980SE |
| K792607 | T3 Uptake (T3U) ReagentsKHQ · Traditional | 01/16/1980SE |
| K792443 | TSH RadioimmunoassayJLW · Traditional | 12/27/1979SE |
| K792442 | Ferritin RadioimmunoassayDBF · Traditional | 12/18/1979SE |
| K791922 | Harleco Brand Clinicard Lipase Test SetCET · Traditional | 11/27/1979SE |
| K792183 | Dade High Density Lipoprotein CholesteroLBS · Traditional | 11/13/1979SE |
| K790776 | Dade Low Ionic Strength Soluition (Liss)KSG · Traditional | 05/23/1979SE |
| K790767 | Immu-Tek Automatic CentrifugeKSN · Traditional | 05/23/1979SE |
Questions and answers
When was Heparin Assay cleared by the FDA?
Heparin Assay (K781479) received a 510(k) decision of Substantially Equivalent on February 15, 1979, 171 days after the submission was received.
What is the product code of K781479?
The FDA product code is KFF – Assay, Heparin, a Class II (moderate risk) device regulated under 21 CFR 864.7525.