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 |