IDS-iSYS Ostase BAP— 510(k) K200475

Name: FDA 510(k) clearance K200475
Creator: U.S. Food and Drug Administration
Published: 2020-09-30

Substantially Equivalent

Immunodiagnostic Systems , Ltd.

FDA 510(k) clearance K200475 for IDS-iSYS Ostase BAP, Substantially Equivalent on 2020-09-30. Applicant: Immunodiagnostic Systems , Ltd.. Device class: 2.

Clearance details

Applicant: Immunodiagnostic Systems , Ltd.
Product code: Code CIN
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2020-02-26
Decision date: 2020-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boldon, GB

Download summary PDF View on FDA.gov ↗

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