The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Cell Cultures-mrc-5 Human Embryo.
| Device ID | K832947 |
| 510k Number | K832947 |
| Device Name: | ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | KIR |
| CFR Regulation Number | 864.2280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-31 |
| Decision Date | 1983-09-29 |