SCANVIEW HER2/NEU FISH SYSTEM— 510(k) K101291

Name: FDA 510(k) clearance K101291
Creator: U.S. Food and Drug Administration
Published: 2010-11-23

Substantially Equivalent

Applied Spectral Imaging , Ltd.

FDA 510(k) clearance K101291 for SCANVIEW HER2/NEU FISH SYSTEM, Substantially Equivalent on 2010-11-23. Applicant: Applied Spectral Imaging , Ltd.. Device class: 2.

Clearance details

Applicant: Applied Spectral Imaging , Ltd.
Product code: Code NTH
Device class: Class 2
Regulation: 21 CFR 866.4700
Advisory panel: Immunology
Date received: 2010-05-07
Decision date: 2010-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

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