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 |