The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Echo Type 9 Cf Antigen.
| Device ID | K844967 |
| 510k Number | K844967 |
| Device Name: | ECHO TYPE 9 CF ANTIGEN |
| Classification | Antigens, Cf (including Cf Control), Echovirus 1-34 |
| Applicant | HILLCREST BIOLOGICALS 3780 WOODRUFF AVE. Long Beach, CA 90808 |
| Contact | Louis D Cullman |
| Correspondent | Louis D Cullman HILLCREST BIOLOGICALS 3780 WOODRUFF AVE. Long Beach, CA 90808 |
| Product Code | GNL |
| CFR Regulation Number | 866.3205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-24 |
| Decision Date | 1985-03-05 |