Afinion HbA1c Dx on Afinion 2— 510(k) K182988

Clearance details

Applicant

Alere Technologies AS

Product code

Code PDJ

Device class

Class 2

Regulation

21 CFR 862.1373

Advisory panel

Clinical Chemistry

Date received

2018-10-29

Decision date

2018-11-29

Decision

Substantially Equivalent

Clearance type

Special

Location

Oslo, NO

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• K180296 — Afinion HbA1c Dx2018-05-07
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• Z-2192-2020 — Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is Abbott Diagnostics Technologies AS, Oslo, Norway. Power supply provided with Alere Afinion AS100 Analyzer, Catalog numbers 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, and 1116980. The firm name on the label is Alere Technologies AS, Oslo, Norway.Class II·Ongoing·Abbott Diagnostics Technologies AS·20200323

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182988.