The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Echo Type 16 Cf Antigen.
| Device ID | K853156 |
| 510k Number | K853156 |
| Device Name: | ECHO TYPE 16 CF ANTIGEN |
| Classification | Antisera, Cf, Echovirus 1-34 |
| 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 | GNK |
| CFR Regulation Number | 866.3205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-30 |
| Decision Date | 1985-11-07 |