Lumipulse G whole PTH— 510(k) K190702

Name: FDA 510(k) clearance K190702
Creator: U.S. Food and Drug Administration
Published: 2019-08-30

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K190702 for Lumipulse G whole PTH, Substantially Equivalent on 2019-08-30. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code CEW
Device class: Class 2
Regulation: 21 CFR 862.1545
Advisory panel: Clinical Chemistry
Date received: 2019-03-18
Decision date: 2019-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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.