The following data is part of a premarket notification filed by Hyclone Laboratories, Inc. with the FDA for Alphacalf Serum.
| Device ID | K884654 |
| 510k Number | K884654 |
| Device Name: | ALPHACALF SERUM |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | HYCLONE LABORATORIES, INC. 1725 SOUTH HYCLONE RD. Logan, UT 84321 |
| Contact | Brim, Ph.d. |
| Correspondent | Brim, Ph.d. HYCLONE LABORATORIES, INC. 1725 SOUTH HYCLONE RD. Logan, UT 84321 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-07 |
| Decision Date | 1988-11-30 |