MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY— 510(k) K042281

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K042281 for MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY, Substantially Equivalent on 2004-09-16. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2004-08-24
Decision date: 2004-09-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

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Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.