EBNA-1 IGM ELISA TEST SYSTEM— 510(k) K982348

Name: FDA 510(k) clearance K982348
Creator: U.S. Food and Drug Administration
Published: 1998-11-25

Substantially Equivalent

Columbia Bioscience, Inc.

FDA 510(k) clearance K982348 for EBNA-1 IGM ELISA TEST SYSTEM, Substantially Equivalent on 1998-11-25. Applicant: Columbia Bioscience, Inc.. Device class: 1.

Clearance details

Applicant: Columbia Bioscience, Inc.
Product code: Product code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1998-07-06
Decision date: 1998-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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