The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for Antiserum To Human Fc.
| Device ID | K790715 |
| 510k Number | K790715 |
| Device Name: | ANTISERUM TO HUMAN FC |
| Classification | Igg (fc Fragment Specific), Antigen, Antiserum, Control |
| Applicant | KENT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DAS |
| CFR Regulation Number | 866.5530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-12 |
| Decision Date | 1979-08-16 |