510(k) DEN180030
- Device
- QMS Plazomicin Immunoassay
- Applicant
- Microgenics Corporation
- 510(k) number
- DEN180030
- Product code
- QDR
- Decision
- Unknown (DENG)
- Decision date
- 2018-11-19
- Date received
- 2018-06-25
- Regulation
- 862.3460
- Classification name
- Plazomicin Test System, Immunoassay
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Minoti Patel
- Address
- 46500 Kato Rd. Fremont CA US 94538 94538
FDA Registration Numbers#
- 3010939897
Source Documents#
510(k) summary PDF not indicated by FDA