AFINION HBALC— 510(k) K050574

Substantially Equivalent

Axis-Shield Poc AS

FDA 510(k) clearance K050574 for AFINION HBALC, Substantially Equivalent on 2005-07-22. Applicant: Axis-Shield Poc AS. Device class: 2.

Clearance details

Applicant: Axis-Shield Poc AS
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2005-03-07
Decision date: 2005-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.