ANTIBODY TO RUBELLA VIRUS— 510(k) K792635

Name: FDA 510(k) clearance K792635
Creator: U.S. Food and Drug Administration
Published: 1980-03-19

Substantially Equivalent

Electro-Nucleonics Laboratories, Inc.

FDA 510(k) clearance K792635 for ANTIBODY TO RUBELLA VIRUS, Substantially Equivalent on 1980-03-19. Applicant: Electro-Nucleonics Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Electro-Nucleonics Laboratories, Inc.
Product code: Code GOK
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1979-12-19
Decision date: 1980-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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