IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...— 510(k) K111938

Name: FDA 510(k) clearance K111938
Creator: U.S. Food and Drug Administration
Published: 2012-02-14

Substantially Equivalent

Immunodiagnostic Systems , Ltd.

FDA 510(k) clearance K111938 for IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL..., Substantially Equivalent on 2012-02-14. Applicant: Immunodiagnostic Systems , Ltd.. Device class: 1.

Clearance details

Applicant: Immunodiagnostic Systems , Ltd.
Product code: Code JJX
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2011-07-08
Decision date: 2012-02-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Boldon, Tyne & Wear, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.