ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY— 510(k) K110934

Clearance details

Applicant

Siemens Healthcare Diagnostics

Product code

Code LCP

Device class

Class 2

Regulation

21 CFR 864.7470

Advisory panel

Hematology

Date received

2011-04-04

Decision date

2011-08-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

East Walpole, MA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110934.