IDS SHBG— 510(k) K190121

Substantially Equivalent

Immunodiagnostic Systems , Ltd.

FDA 510(k) clearance K190121 for IDS SHBG, Substantially Equivalent on 2019-06-17. Applicant: Immunodiagnostic Systems , Ltd.. Device class: 1.

Clearance details

Applicant: Immunodiagnostic Systems , Ltd.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 2019-01-25
Decision date: 2019-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boldon, GB

Download summary PDF View on FDA.gov ↗

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