The following data is part of a premarket notification filed by Burroughs Wellcome Co. with the FDA for Sac-cel.
| Device ID | K813508 |
| 510k Number | K813508 |
| Device Name: | SAC-CEL |
| Classification | Second Antibody (species Specific Anti-animal Gamma Globulin) |
| Applicant | BURROUGHS WELLCOME CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTS |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-15 |
| Decision Date | 1981-12-29 |