510(k) K162540
- Device
- INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF And Heparin LMW Controls
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH
- 510(k) number
- K162540
- Product code
- KFF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-08-22
- Date received
- 2016-09-12
- Regulation
- 864.7525
- Classification name
- Assay, Heparin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROSE T MARINELLI
- Address
- Emil-Von Behring St. 76 Marburg DE 35041 35041
FDA Registration Numbers#
- 3004434070
- 3037000637
- 2431530
- 1618982
- 3003691680
- 3002721930
- 9710666
- 9610806
- 1217183
- 2245451
Source Documents#
Other 510(k) Records For Product Code KFF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213464 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2022-10-04 |
| K111822 | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH | Diagnostica Stago, Inc. | 2011-10-26 |
| K090209 | HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS | Instrumentation Laboratory CO | 2009-06-02 |
| K050367 | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 | Hyphen Biomed | 2006-05-24 |
| K013305 | ENOXAPARIN TEST CARD | Cardiovascular Diagnostics, Inc. | 2002-08-23 |
| K013637 | ACTICHROME HEPARIN (ANTI-FIIA) | American Diagnostica, Inc. | 2002-04-16 |
| K013318 | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 | American Diagnostica, Inc. | 2002-03-08 |
| K010455 | ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN | Diagnostica-Stago | 2001-06-07 |
| K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS | International Technidyne Corp. | 2001-06-06 |
| K983178 | COAMATIC HEPARIN | Instrumentation Laboratory CO | 1998-11-03 |
| K980242 | IL TEST HEPARIN | Instrumentation Laboratory CO | 1998-03-19 |
| K972209 | SPECTROLYSE HEPARIN (ANTI-IIA) | Medical Diagnostic Technologies, Inc. | 1997-08-12 |
| K965076 | MDA HEPARIN ANTI-X ASSAY | Organon Teknika Corp. | 1997-03-18 |
| K952667 | CHROM Z-HEPARIN, CAT. NO 5242 | Helena Laboratories | 1996-02-14 |
| K952514 | COACUTE HEPARIN | Chromogenix AB | 1995-11-20 |
Legacy Summary#
summary
FDA Review#
Decision Summary