RUBELLA VIRUS ANTIGENS & CONTROLS— 510(k) K802937

Name: FDA 510(k) clearance K802937
Creator: U.S. Food and Drug Administration
Published: 1980-12-31

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K802937 for RUBELLA VIRUS ANTIGENS & CONTROLS, Substantially Equivalent on 1980-12-31. Applicant: Orion Diagnostica, Inc.. Device class: 2.

Clearance details

Applicant: Orion Diagnostica, Inc.
Product code: Code GON
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1980-11-19
Decision date: 1980-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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