QMS Plazomicin Immunoassay
FDA 510(k) clearance DEN180030 · decided 2018-11-19
Clearance details
- K-number
- DEN180030
- Device name
- QMS Plazomicin Immunoassay
- Applicant
- Microgenics Corporation
- Decision
- Unknown
- Date received
- 2018-06-25
- Decision date
- 2018-11-19
- Days to decision
- 147 days
- Clearance type
- Direct
- Product code
- QDR
- Device class
- 2
- Regulation number
- 862.3460
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.