ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C— 510(k) K121842

Clearance details

Applicant

Axis-Shield Diagnostics, Ltd.

Product code

Code LCP

Device class

Class 2

Regulation

21 CFR 864.7470

Advisory panel

Hematology

Date received

2012-06-25

Decision date

2012-12-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Dundee, GB

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121842.