AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS— 510(k) K072686

Name: FDA 510(k) clearance K072686
Creator: U.S. Food and Drug Administration
Published: 2008-03-17

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

FDA 510(k) clearance K072686 for AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS, Substantially Equivalent on 2008-03-17. Applicant: Axis-Shield Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2007-09-24
Decision date: 2008-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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