Spectrolyse Heparin Kit
FDA 510(k) K923499 · Biopool AB
510(k) numberK923499
Submission
- Device name
- Spectrolyse Heparin Kit
- Applicant
- Biopool AB
Ontario, L7l 6b8, CA - Received
- July 15, 1992
- Decision date
- January 27, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 |
|---|---|---|
| K941752 | Spectrolyse Antiplasmin KitGGP · Traditional | 09/25/1995SESK |
| K942087 | Biopool VWF Eld Kit and VWF Eld Bulk PlatesGGP · Traditional | 07/13/1995SE |
| K934314 | Tintelizer(R) TpaGGP · Traditional | 02/23/1994SE |
| K932463 | Bioclot laGIR · Traditional | 09/27/1993SE |
| K920668 | Minutex D-Dimer Latex TestGHH · Traditional | 10/16/1992SE |
| K922782 | Spectrolyse/Pl Pai KitGGP · Traditional | 10/09/1992SE |
| K915163 | Protein S Eid Kit and Protein S Eid Bulk PlatesGGP · Traditional | 01/06/1992SE |
| K914307 | Spectrolyse Protein C KitGGP · Traditional | 12/09/1991SE |
| K912025 | Spectrolyse Plasminogen SK KitGGP · Traditional | 08/22/1991SE |
| K902566 | Biopool Protein C Eid Kit and Bulk PlatesGGP · Traditional | 08/09/1990SE |
Questions and answers
When was Spectrolyse Heparin Kit cleared by the FDA?
Spectrolyse Heparin Kit (K923499) received a 510(k) decision of Substantially Equivalent on January 27, 1994, 561 days after the submission was received.
What is the product code of K923499?
The FDA product code is KFF – Assay, Heparin, a Class II (moderate risk) device regulated under 21 CFR 864.7525.