Il Test 97575-15, Heparin Assay
FDA 510(k) K864211 · Instrumentation Laboratory CO
510(k) numberK864211
Submission
- Device name
- Il Test 97575-15, Heparin Assay
- Applicant
- Instrumentation Laboratory CO
Lexington, MA, US - Received
- October 28, 1986
- Decision date
- January 5, 1987
- 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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|---|---|---|---|
| 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 |
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| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
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Questions and answers
When was Il Test 97575-15, Heparin Assay cleared by the FDA?
Il Test 97575-15, Heparin Assay (K864211) received a 510(k) decision of Substantially Equivalent on January 5, 1987, 69 days after the submission was received.
What is the product code of K864211?
The FDA product code is KFF – Assay, Heparin, a Class II (moderate risk) device regulated under 21 CFR 864.7525.