IDS-iSYS Intact PTHN— 510(k) K161158

Substantially Equivalent

Immunodiagnostic Systems , Ltd.

FDA 510(k) clearance K161158 for IDS-iSYS Intact PTHN, Substantially Equivalent on 2017-01-31. Applicant: Immunodiagnostic Systems , Ltd..

Clearance details

Applicant: Immunodiagnostic Systems , Ltd.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2016-04-25
Decision date: 2017-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boldon, GB

Download summary PDF View on FDA.gov ↗

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.