The following data is part of a premarket notification filed by Hyclone Laboratories, Inc. with the FDA for Bovine Calf Serum Supplemented #a-2159.
Device ID | K880471 |
510k Number | K880471 |
Device Name: | BOVINE CALF SERUM SUPPLEMENTED #A-2159 |
Classification | Sera, Animal And Human |
Applicant | HYCLONE LABORATORIES, INC. 1725 SOUTH HYCLONE RD. Logan, UT 84321 |
Contact | Rex S Spendlove,phd |
Correspondent | Rex S Spendlove,phd 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 | 1988-02-03 |
Decision Date | 1988-04-04 |