The following data is part of a premarket notification filed by Biosan Laboratories, Inc. with the FDA for Normal Goat Serum.
| Device ID | K833318 |
| 510k Number | K833318 |
| Device Name: | NORMAL GOAT SERUM |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | BIOSAN LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DHX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-26 |
| Decision Date | 1984-01-03 |