SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI— 510(k) K883670

Name: FDA 510(k) clearance K883670
Creator: U.S. Food and Drug Administration
Published: 1989-04-28

Substantially Equivalent

Electro-Nucleonics, Inc.

FDA 510(k) clearance K883670 for SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI, Substantially Equivalent on 1989-04-28. Applicant: Electro-Nucleonics, Inc.. Device class: 1.

Clearance details

Applicant: Electro-Nucleonics, Inc.
Product code: Code GNP
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1988-08-18
Decision date: 1989-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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