ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
FDA 510(k) clearance K182619 · decided 2019-04-12
Clearance details
- K-number
- K182619
- Device name
- ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
- Applicant
- Genmark Diagnostics, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2018-09-24
- Decision date
- 2019-04-12
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- PEN
- Device class
- 2
- Regulation number
- 866.3365
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.