Afinion Hbalc

FDA 510(k) K050574 · Axis-Shield Poc AS

Substantially Equivalent

510(k) numberK050574

Submission

Device name
Afinion Hbalc
Applicant
Axis-Shield Poc AS
San Diego, CA, US
Received
March 7, 2005
Decision date
July 22, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LCP – Assay, Glycosylated Hemoglobin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7470
Specialty
Hematology

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More from Alfa Wassermann Diagnostic Technologies, LLC

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K132031Afinion Lipid Panel and Afinion Lipid Panel ControlCHH · Traditional 03/21/2014SE
K110056Afinion AnalyzerLCP · Traditional 02/15/2011SE
K072409Afinion Acr and Acr ControlJFY · Traditional 02/12/2008SE

Questions and answers

When was Afinion Hbalc cleared by the FDA?

Afinion Hbalc (K050574) received a 510(k) decision of Substantially Equivalent on July 22, 2005, 137 days after the submission was received.

What is the product code of K050574?

The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.