ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS— 510(k) K081895

Clearance details

Applicant

Siemens Medical Solutions Diagnostics

Product code

Code LCP

Device class

Class 2

Regulation

21 CFR 864.7470

Advisory panel

Hematology

Date received

2008-07-03

Decision date

2009-01-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tarrytown, NY, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081895.