ANTIBODY TO VARICELLA-ZOSTER VIRUS— 510(k) K800787

Name: FDA 510(k) clearance K800787
Creator: U.S. Food and Drug Administration
Published: 1980-07-14

Substantially Equivalent

Electro-Nucleonics Laboratories, Inc.

FDA 510(k) clearance K800787 for ANTIBODY TO VARICELLA-ZOSTER VIRUS, Substantially Equivalent on 1980-07-14. Applicant: Electro-Nucleonics Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Electro-Nucleonics Laboratories, Inc.
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1980-04-08
Decision date: 1980-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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