The following data is part of a premarket notification filed by Bioassay Systems Research Corp. with the FDA for Cell Culture Lines.
| Device ID | K780869 |
| 510k Number | K780869 |
| Device Name: | CELL CULTURE LINES |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | BIOASSAY SYSTEMS RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KIR |
| CFR Regulation Number | 864.2280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-05-30 |
| Decision Date | 1978-08-14 |