510(k) K110303
K110303 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "STRATUS CS ACUTE CARE D-DIMER". The FDA issued a decision of Substantially Equivalent on May 16, 2011. 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
- May 16, 2011
- Date Received
- February 1, 2011
- 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