MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT— 510(k) K111527

Name: FDA 510(k) clearance K111527
Creator: U.S. Food and Drug Administration
Published: 2011-08-03

Substantially Equivalent

Eragen Biosciences, Inc.

FDA 510(k) clearance K111527 for MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT, Substantially Equivalent on 2011-08-03. Applicant: Eragen Biosciences, Inc.. Device class: 2.

Clearance details

Applicant: Eragen Biosciences, Inc.
Product code: Code OQO
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2011-06-01
Decision date: 2011-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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