VITROS AFP— 510(k) K213626

Clearance details

Applicant

Ortho Clinical Diagnostics

Product code

Code LOJ

Device class

Class 2

Regulation

21 CFR 866.6010

Advisory panel

Immunology

Date received

2021-11-17

Decision date

2022-06-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Pencoed, GB

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