510(k) K091916
K091916 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "INNOVANCE D-DIMER, MODEL OPBP09". The FDA issued a decision of Substantially Equivalent on October 29, 2009. The device falls under product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 864.7320. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2009
- Date Received
- June 30, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 864.7320
- Review Panel
- HE
- Submission Type