ABBOTT PLEX-ID FLU ASSAY— 510(k) K121003

Name: FDA 510(k) clearance K121003
Creator: U.S. Food and Drug Administration
Published: 2012-12-21

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K121003 for ABBOTT PLEX-ID FLU ASSAY, Substantially Equivalent on 2012-12-21. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code OCC
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2012-04-02
Decision date: 2012-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

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.