510(k) K182619
K182619 is an FDA 510(k) premarket notification submitted by Genmark Diagnostics, Incorporated for the device "ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel". The FDA issued a decision of Substantially Equivalent on April 12, 2019. The device falls under product code PEN (Gram-Negative Bacteria And Associated Resistance Markers), a Class II device regulated under 21 CFR 866.3365. Genmark Diagnostics, Incorporated has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2019
- Date Received
- September 24, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gram-Negative Bacteria And Associated Resistance Markers
- Device Class
- Class II
- Regulation Number
- 866.3365
- Review Panel
- MI
- Submission Type
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.