510(k) K955799
K955799 is an FDA 510(k) premarket notification submitted by Sienna Biotech, Inc. for the device "COPALIS CMV TOTAL ANTIBODY ASSAY". The FDA issued a decision of Substantially Equivalent on July 10, 1996. The device falls under product code LJO (Antigen, Iha, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Sienna Biotech, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1996
- Date Received
- December 22, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Iha, Cytomegalovirus
- Device Class
- Class II
- Regulation Number
- 866.3175
- Review Panel
- MI
- Submission Type