The following data is part of a premarket notification filed by Cell Culture Laboratories with the FDA for Animal And Human Sera.
| Device ID | K881287 |
| 510k Number | K881287 |
| Device Name: | ANIMAL AND HUMAN SERA |
| Classification | Sera, Animal And Human |
| Applicant | CELL CULTURE LABORATORIES 4400 EMERY INDUSTRIAL PKWY. Cleveland, OH 44128 |
| Contact | Charles D Clark |
| Correspondent | Charles D Clark CELL CULTURE LABORATORIES 4400 EMERY INDUSTRIAL PKWY. Cleveland, OH 44128 |
| Product Code | KIS |
| CFR Regulation Number | 864.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-28 |
| Decision Date | 1988-04-05 |