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 |