The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Chlamydia Group Cf Antigen.
Device ID | K844868 |
510k Number | K844868 |
Device Name: | CHLAMYDIA GROUP CF ANTIGEN |
Classification | Antigen, Cf, Psittacosis (chlamydia Group) |
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 | GPW |
CFR Regulation Number | 866.3120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-14 |
Decision Date | 1985-03-05 |