The following data is part of a premarket notification filed by Hyclone Laboratories, Inc. with the FDA for Defined Equine Serum #a-3311.
Device ID | K870469 |
510k Number | K870469 |
Device Name: | DEFINED EQUINE SERUM #A-3311 |
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 |