ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG— 510(k) K895468

Name: FDA 510(k) clearance K895468
Creator: U.S. Food and Drug Administration
Published: 1990-03-13

Substantially Equivalent

Orgenics, Ltd.

FDA 510(k) clearance K895468 for ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG, Substantially Equivalent on 1990-03-13. Applicant: Orgenics, Ltd.. Device class: 1.

Clearance details

Applicant: Orgenics, Ltd.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1989-09-11
Decision date: 1990-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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