EliA RF IgM Immunoassay— 510(k) K182747

Clearance details

Applicant

Phadia AB

Product code

Code DHR

Device class

Class 2

Regulation

21 CFR 866.5775

Advisory panel

Immunology

Date received

2018-09-28

Decision date

2018-12-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Uppsala, SE

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182747.