ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01— 510(k) K060818

Clearance details

Applicant

Biokit, S.A.

Product code

Code CDZ

Device class

Class 1

Regulation

21 CFR 862.1680

Advisory panel

Clinical Chemistry

Date received

2006-03-27

Decision date

2007-01-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Barcelona, ES

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060818.