The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for Human C1 Inactivator Or C-1 Esterase Inhibitor Radial Immunodiffusion Kit.
| Device ID | K951967 |
| 510k Number | K951967 |
| Device Name: | HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT |
| Classification | Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control |
| Applicant | KENT LABORATORIES, INC. 23404 N.E. 8TH ST. Redmond, WA 98053 |
| Contact | Donald A Jorgensen |
| Correspondent | Donald A Jorgensen KENT LABORATORIES, INC. 23404 N.E. 8TH ST. Redmond, WA 98053 |
| Product Code | DBA |
| CFR Regulation Number | 866.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-27 |
| Decision Date | 1995-05-30 |