KFF — Assay, Heparin Class II
FDA product code KFF covers "Assay, Heparin", a Class II medical device regulated under 21 CFR 864.7525. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KFF
- Device Class
- Class II
- Regulation Number
- 864.7525
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K213464 | instrumentation laboratory | HemosIL Liquid Anti-Xa | October 4, 2022 |
| K162540 | siemens healthcare diagnostics prodcts | INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Hep | August 22, 2017 |
| K111822 | diagnostica stago | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / | October 26, 2011 |
| K090209 | instrumentation laboratory | HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS | June 2, 2009 |
| K050367 | hyphen biomed | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 | May 24, 2006 |
| K013305 | cardiovascular diagnostics | ENOXAPARIN TEST CARD | August 23, 2002 |
| K013637 | american diagnostica | ACTICHROME HEPARIN (ANTI-FIIA) | April 16, 2002 |
| K013318 | american diagnostica | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 | March 8, 2002 |
| K010455 | diagnostica-stago | ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN | June 7, 2001 |
| K010193 | international technidyne | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS | June 6, 2001 |
| K983178 | instrumentation laboratory | COAMATIC HEPARIN | November 3, 1998 |
| K980242 | instrumentation laboratory | IL TEST HEPARIN | March 19, 1998 |
| K972209 | medical diagnostic technologies | SPECTROLYSE HEPARIN (ANTI-IIA) | August 12, 1997 |
| K965076 | organon teknika | MDA HEPARIN ANTI-X ASSAY | March 18, 1997 |
| K952667 | helena laboratories | CHROM Z-HEPARIN, CAT. NO 5242 | February 14, 1996 |
| K952514 | chromogenix | COACUTE HEPARIN | November 20, 1995 |
| K943519 | american bioproducts | HBPM/LMWH CONTROL KIT | September 26, 1995 |
| K943514 | american bioproducts | THE HEPANORM HBPM/LMWH KIT | September 26, 1995 |
| K943520 | american bioproducts | HEPARIN CONTROL KIT | September 26, 1995 |
| K943516 | american bioproducts | ROTACHROM HBPM/LMWH TEST KIT | August 31, 1995 |