ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel— 510(k) K181663

Substantially Equivalent

Genmark Diagnostics, Incorporated

FDA 510(k) clearance K181663 for ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel, Substantially Equivalent on 2018-12-20. Applicant: Genmark Diagnostics, Incorporated.

Clearance details

Applicant: Genmark Diagnostics, Incorporated
Product code: Code PAM
Advisory panel: Microbiology
Date received: 2018-06-25
Decision date: 2018-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PAM

product code PAM

Death: 6
Malfunction: 598
Total: 604

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.