510(k) K813508
K813508 is an FDA 510(k) premarket notification submitted by Burroughs Wellcome Co. for the device "SAC-CEL". The FDA issued a decision of Substantially Equivalent on December 29, 1981. The device falls under product code KTS (Second Antibody (Species Specific Anti-Animal Gamma Globulin)), a Class II device regulated under 21 CFR 866.5510. Burroughs Wellcome Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1981
- Date Received
- December 15, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Second Antibody (Species Specific Anti-Animal Gamma Globulin)
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type