POLIO TYPE I CF ANTIGEN, & TYPE II, III— 510(k) K853278

Name: FDA 510(k) clearance K853278
Creator: U.S. Food and Drug Administration
Published: 1985-11-07

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K853278 for POLIO TYPE I CF ANTIGEN, & TYPE II, III, Substantially Equivalent on 1985-11-07. Applicant: Hillcrest Biologicals. Device class: 1.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code GOG
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1985-08-05
Decision date: 1985-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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