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

Name: FDA 510(k) clearance K112603
Creator: U.S. Food and Drug Administration
Published: 2011-11-04

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.. Device class: 1.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JJX
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2011-09-07
Decision date: 2011-11-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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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.