ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT— 510(k) K891393

Name: FDA 510(k) clearance K891393
Creator: U.S. Food and Drug Administration
Published: 1989-06-23

Substantially Equivalent

Orgenics, Ltd.

FDA 510(k) clearance K891393 for ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT, Substantially Equivalent on 1989-06-23. Applicant: Orgenics, Ltd.. Device class: 2.

Clearance details

Applicant: Orgenics, Ltd.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1989-03-14
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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