VIDAS LYME SCREEN II— 510(k) K943812

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K943812 for VIDAS LYME SCREEN II, Substantially Equivalent on 1995-06-13. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1994-08-05
Decision date: 1995-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.