510(k) K080916
K080916 is an FDA 510(k) premarket notification submitted by Sebia for the device "CAPILLARYS URINE". The FDA issued a decision of Substantially Equivalent on July 1, 2008. The device falls under product code JKM (Immunochemical, Bence-Jones Protein), a Class II device regulated under 21 CFR 866.5150. Sebia has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2008
- Date Received
- April 2, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunochemical, Bence-Jones Protein
- Device Class
- Class II
- Regulation Number
- 866.5150
- Review Panel
- IM
- Submission Type