CHLAMYDIA GROUP CF ANTIGEN— 510(k) K844868

Name: FDA 510(k) clearance K844868
Creator: U.S. Food and Drug Administration
Published: 1985-03-05

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K844868 for CHLAMYDIA GROUP CF ANTIGEN, Substantially Equivalent on 1985-03-05. Applicant: Hillcrest Biologicals. Device class: 1.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code GPW
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1984-12-14
Decision date: 1985-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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K872700 — YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN1987-10-15
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K811570 — ANTIBODY TO CHLAMYDIA TRACHOMATIS1981-07-23

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Data sourced from openFDA. This site is unofficial and independent of the FDA.