The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Varelisa Sm Antibodies.
Device ID | K000312 |
510k Number | K000312 |
Device Name: | VARELISA SM ANTIBODIES |
Classification | Anti-sm Antibody, Antigen And Control |
Applicant | PHARMACIA & UPJOHN CO. 5094 ST. ANDREWS DR. Westervillle, OH 43082 |
Contact | Karen Matis |
Correspondent | Karen Matis PHARMACIA & UPJOHN CO. 5094 ST. ANDREWS DR. Westervillle, OH 43082 |
Product Code | LKP |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-01 |
Decision Date | 2000-03-17 |