GENASIS HIPATH IHC FAMILY— 510(k) K140957

Name: FDA 510(k) clearance K140957
Creator: U.S. Food and Drug Administration
Published: 2015-01-15

Substantially Equivalent

Applied Spectral Imaging , Ltd.

FDA 510(k) clearance K140957 for GENASIS HIPATH IHC FAMILY, Substantially Equivalent on 2015-01-15. Applicant: Applied Spectral Imaging , Ltd.. Device class: 2.

Clearance details

Applicant: Applied Spectral Imaging , Ltd.
Product code: Code NQN
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2014-04-14
Decision date: 2015-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

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