ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS— 510(k) K112603

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K112603 for ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS, Substantially Equivalent on 2011-11-04. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2011-09-07
Decision date: 2011-11-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chaska, MN, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.