BANDVIEW SYSTEM— 510(k) K012103

Name: FDA 510(k) clearance K012103
Creator: U.S. Food and Drug Administration
Published: 2001-09-14

Substantially Equivalent

Applied Spectral Imaging , Ltd.

FDA 510(k) clearance K012103 for BANDVIEW SYSTEM, Substantially Equivalent on 2001-09-14. Applicant: Applied Spectral Imaging , Ltd.. Device class: 2.

Clearance details

Applicant: Applied Spectral Imaging , Ltd.
Product code: Code LNJ
Device class: Class 2
Regulation: 21 CFR 864.5260
Advisory panel: Hematology
Date received: 2001-07-05
Decision date: 2001-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Ananna 43373, IL

Download summary PDF View on FDA.gov ↗

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