FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADVIA 2120i, ADVIA 2120
K Number: K162977
·
Decision Aug 11, 2017
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
92
Review Days
289
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Basic Information
- Device Name
- ADVIA 2120i, ADVIA 2120
- K Number
- K162977
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics
- Date Received
- October 26, 2016
- Decision Date
- August 11, 2017
- Product Code
- GKZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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