510(k) K050278
K050278 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL D-DIMER". The FDA issued a decision of Substantially Equivalent on March 10, 2005. 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. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2005
- Date Received
- February 7, 2005
- 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