ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel— 510(k) K182619
Substantially EquivalentGenmark Diagnostics, Incorporated
FDA 510(k) clearance K182619 for ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel, Substantially Equivalent on 2019-04-12. Applicant: Genmark Diagnostics, Incorporated.
Clearance details
- Applicant
- Genmark Diagnostics, Incorporated
- Product code
- Code PEN
- Advisory panel
- Microbiology
- Date received
- Decision date
- 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, 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.