Access Intact PTH— 510(k) K232791

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K232791 for Access Intact PTH, Substantially Equivalent on 2024-03-01. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2023-09-11
Decision date: 2024-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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.