INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
FDA 510(k) clearance K162540 · decided 2017-08-22
Clearance details
- K-number
- K162540
- Device name
- INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
- Applicant
- Siemens Healthcare Diagnostics Prodcts GmbH
- Decision
- Substantially Equivalent
- Date received
- 2016-09-12
- Decision date
- 2017-08-22
- Days to decision
- 344 days
- Clearance type
- Traditional
- Product code
- KFF
- Device class
- 2
- Regulation number
- 864.7525
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Marburg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.