VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE— 510(k) K082329

Name: FDA 510(k) clearance K082329
Creator: U.S. Food and Drug Administration
Published: 2009-08-05

Substantially Equivalent

Viramed Biotech AG

FDA 510(k) clearance K082329 for VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE, Substantially Equivalent on 2009-08-05. Applicant: Viramed Biotech AG. Device class: 2.

Clearance details

Applicant: Viramed Biotech AG
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2008-08-14
Decision date: 2009-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oceanside, CA, US

Download summary PDF View on FDA.gov ↗

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