ARCHITECT SHBG— 510(k) K152185

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K152185 for ARCHITECT SHBG, Substantially Equivalent on 2016-02-11. Applicant: Biokit, S.A.. Device class: 1.

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: 2015-08-05
Decision date: 2016-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lliça D'Amunt, ES

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.