510(k) K050286
K050286 is an FDA 510(k) premarket notification submitted by Biomedical Diagnostics (Bmd) SA for the device "FIDIS CONNECTIVE 8". The FDA issued a decision of Substantially Equivalent on October 3, 2005. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Biomedical Diagnostics (Bmd) SA has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2005
- Date Received
- February 7, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extractable Antinuclear Antibody, Antigen And Control
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type