The following data is part of a premarket notification filed by Hyclone Laboratories, Inc. with the FDA for Defined Fetal Bovine Serum #a-1111.
| Device ID | K870463 |
| 510k Number | K870463 |
| Device Name: | DEFINED FETAL BOVINE SERUM #A-1111 |
| Classification | Sera, Animal And Human |
| Applicant | HYCLONE LABORATORIES, INC. 1725 SOUTH HYCLONE RD. Logan, UT 84321 |
| Contact | Rex S Spendlove |
| Correspondent | Rex S Spendlove HYCLONE LABORATORIES, INC. 1725 SOUTH HYCLONE RD. Logan, UT 84321 |
| Product Code | KIS |
| CFR Regulation Number | 864.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-03-24 |