The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for Human C1q Radial Immunodiffusion Kit.
Device ID | K951968 |
510k Number | K951968 |
Device Name: | HUMAN C1Q RADIAL IMMUNODIFFUSION KIT |
Classification | Complement C1q, 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 | DAK |
CFR Regulation Number | 866.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-27 |
Decision Date | 1995-05-30 |