510(k) K083602
K083602 is an FDA 510(k) premarket notification submitted by SENTINEL CH. SpA for the device "KAPPA LIGHT CHAINS". The FDA issued a decision of Substantially Equivalent on September 3, 2009. The device falls under product code DFH (Kappa, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. SENTINEL CH. SpA has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 2009
- Date Received
- December 5, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kappa, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5550
- Review Panel
- IM
- Submission Type