ACCESS TOTAL BHCG (5TH IS)— 510(k) K130020

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K130020 for ACCESS TOTAL BHCG (5TH IS), Substantially Equivalent on 2013-10-01. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 2013-01-03
Decision date: 2013-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

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.