The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Goat Serum (29-391-54).
Device ID | K860752 |
510k Number | K860752 |
Device Name: | GOAT SERUM (29-391-54) |
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 |