510(k) K070486
K070486 is an FDA 510(k) premarket notification submitted by Sebia, Inc. for the device "CAPILLARYS URINE (PN 2012)". The FDA issued a decision of Substantially Equivalent on December 21, 2007. The device falls under product code JKM (Immunochemical, Bence-Jones Protein), a Class II device regulated under 21 CFR 866.5150. Sebia, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2007
- Date Received
- February 20, 2007
- Clearance Type
- Traditional
- 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