510(k) K213236— ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

Substantially Equivalent

Genmark Diagnostics, Incorporated

Clearance details

Applicant: Genmark Diagnostics, Incorporated
Product code: Code PEN
Advisory panel: Microbiology
Date received: 2021-09-30
Decision date: 2022-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Adverse events under product code PEN

product code PEN

Death: 7
Total: 7

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.