VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA— 510(k) K821542

Name: FDA 510(k) clearance K821542
Creator: U.S. Food and Drug Administration
Published: 1982-06-03

Substantially Equivalent

Electro-Nucleonics Laboratories, Inc.

FDA 510(k) clearance K821542 for VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA, Substantially Equivalent on 1982-06-03. Applicant: Electro-Nucleonics Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Electro-Nucleonics Laboratories, Inc.
Product code: Code LCR
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1982-05-24
Decision date: 1982-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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