The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Gamma-free Horse Serum.
| Device ID | K860762 |
| 510k Number | K860762 |
| Device Name: | GAMMA-FREE HORSE SERUM |
| Classification | Sera, Animal And Human |
| Applicant | FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean, VA 22102 |
| Contact | Bishop, Ph.d. |
| Correspondent | Bishop, Ph.d. FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean, VA 22102 |
| Product Code | KIS |
| CFR Regulation Number | 864.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-28 |
| Decision Date | 1986-03-10 |