The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Cell Culture Refeed Medium.
| Device ID | K850537 |
| 510k Number | K850537 |
| Device Name: | CELL CULTURE REFEED MEDIUM |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Contact | Louis C Cullman |
| Correspondent | Louis C Cullman HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-11 |
| Decision Date | 1985-03-20 |