Optilite Rheumatoid Factor Kit— 510(k) K162263

Clearance details

Applicant

The Binding Site Group , Ltd.

Product code

Code DHR

Device class

Class 2

Regulation

21 CFR 866.5775

Advisory panel

Immunology

Date received

2016-08-11

Decision date

2017-05-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Birmingham, GB

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162263.