Cleared Traditional

ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS

K081895 · Siemens Medical Solutions Diagnostics · Chemistry
Jan 2009
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K081895 is an FDA 510(k) clearance for the ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Siemens Medical Solutions Diagnostics (New York, US). The FDA issued a Cleared decision on January 8, 2009, 189 days after receiving the submission on July 3, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K081895 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2008
Decision Date January 08, 2009
Days to Decision 189 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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