CYTOMEGALO VIRUS & CONTROLS— 510(k) K802930

Name: FDA 510(k) clearance K802930
Creator: U.S. Food and Drug Administration
Published: 1981-01-09

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K802930 for CYTOMEGALO VIRUS & CONTROLS, Substantially Equivalent on 1981-01-09. Applicant: Orion Diagnostica, Inc.. Device class: 2.

Clearance details

Applicant: Orion Diagnostica, Inc.
Product code: Code GQH
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1980-11-19
Decision date: 1981-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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