Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit— 510(k) K150658

Clearance details

Applicant

The Binding Site Group , Ltd.

Product code

Code DFH

Device class

Class 2

Regulation

21 CFR 866.5550

Advisory panel

Immunology

Date received

2015-03-13

Decision date

2015-08-26

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 K150658.