IDS-ISYS INTACT PTH— 510(k) K103325

Name: FDA 510(k) clearance K103325
Creator: U.S. Food and Drug Administration
Published: 2012-02-03

Substantially Equivalent

Immunodiagnostic Systems , Ltd.

FDA 510(k) clearance K103325 for IDS-ISYS INTACT PTH, Substantially Equivalent on 2012-02-03. Applicant: Immunodiagnostic Systems , Ltd.. Device class: 2.

Clearance details

Applicant: Immunodiagnostic Systems , Ltd.
Product code: Code CEW
Device class: Class 2
Regulation: 21 CFR 862.1545
Advisory panel: Clinical Chemistry
Date received: 2010-11-12
Decision date: 2012-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boldon, Tyne & Wear, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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