IS EBV-EBNA-1 IGG ELISA TEST SYSTEM— 510(k) K981829

Name: FDA 510(k) clearance K981829
Creator: U.S. Food and Drug Administration
Published: 1999-02-16

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K981829 for IS EBV-EBNA-1 IGG ELISA TEST SYSTEM, Substantially Equivalent on 1999-02-16. Applicant: Diamedix Corp.. Device class: 1.

Clearance details

Applicant: Diamedix Corp.
Product code: Code GNP
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1998-05-22
Decision date: 1999-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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