Dimension Visa HBA1C, Model K3105A

FDA 510(k) K102045 · Siemens Heatlhcare Diagnostics, Inc.

Substantially Equivalent

510(k) numberK102045

Submission

Device name
Dimension Visa HBA1C, Model K3105A
Applicant
Siemens Heatlhcare Diagnostics, Inc.
Newark, DE, US
Received
July 21, 2010
Decision date
February 14, 2011
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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Questions and answers

When was Dimension Visa HBA1C, Model K3105A cleared by the FDA?

Dimension Visa HBA1C, Model K3105A (K102045) received a 510(k) decision of Substantially Equivalent on February 14, 2011, 208 days after the submission was received.

What is the product code of K102045?

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