DeviceClearance

K181663

Substantially Equivalent

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel

Applicant
Genmark Diagnostics, Incorporated
Product code
PAM
Advisory panel
Microbiology
Date received
Decision date
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, through . 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.