IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers— 510(k) K161082

Substantially Equivalent

Immunodiagnostic Systems , Ltd.

FDA 510(k) clearance K161082 for IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers, Substantially Equivalent on 2016-05-17. Applicant: Immunodiagnostic Systems , Ltd..

Clearance details

Applicant: Immunodiagnostic Systems , Ltd.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2016-04-18
Decision date: 2016-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boldon, GB

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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.