CamAPS FX— 510(k) K232603

Substantially Equivalent

Camdiab , Ltd.

FDA 510(k) clearance K232603 for CamAPS FX, Substantially Equivalent on 2024-05-23. Applicant: Camdiab , Ltd..

Clearance details

Applicant: Camdiab , Ltd.
Product code: Code QJI
Advisory panel: Clinical Chemistry
Date received: 2023-08-28
Decision date: 2024-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code QJI

product code QJI

Other: 3
Total: 3

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.