The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Coxsackie B Series Cf Antigens.
| Device ID | K850003 |
| 510k Number | K850003 |
| Device Name: | COXSACKIE B SERIES CF ANTIGENS |
| Classification | Antigens, Cf (including Cf Control), Coxsackievirus A 1-24, B 1-6 |
| 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 | GNG |
| CFR Regulation Number | 866.3145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-02 |
| Decision Date | 1985-03-05 |