FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
QMS Plazomicin Immunoassay
K Number: DEN180030
·
Decision Nov 19, 2018
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
20
Review Days
147
Basic Information
- Device Name
- QMS Plazomicin Immunoassay
- K Number
- DEN180030
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 862.3460
- Medical Specialty
- Clinical Toxicology
- Decision
- Unknown
- Applicant
- Microgenics Corporation
- Date Received
- June 25, 2018
- Decision Date
- November 19, 2018
- Product Code
- QDR
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QDR | Plazomicin Test System, Immunoassay | FDA class 2 | Clinical Toxicology |
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