MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711— 510(k) K100336

Name: FDA 510(k) clearance K100336
Creator: U.S. Food and Drug Administration
Published: 2010-05-12

Substantially Equivalent

Eragen Biosciences

FDA 510(k) clearance K100336 for MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711, Substantially Equivalent on 2010-05-12. Applicant: Eragen Biosciences. Device class: 2.

Clearance details

Applicant: Eragen Biosciences
Product code: Product code OQO
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2010-02-05
Decision date: 2010-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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