IDS Cortisol— 510(k) K202136

Substantially Equivalent

Immunodiagnostic Systems , Ltd.

FDA 510(k) clearance K202136 for IDS Cortisol, Substantially Equivalent on 2021-04-13. Applicant: Immunodiagnostic Systems , Ltd.. Device class: 2.

Clearance details

Applicant: Immunodiagnostic Systems , Ltd.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 2020-07-31
Decision date: 2021-04-13
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.