FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Atellica CH Magnesium (Mg)
K Number: K162399
·
Decision Jan 19, 2017
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
89
Applicant Total
32
Review Days
146
Basic Information
- Device Name
- Atellica CH Magnesium (Mg)
- K Number
- K162399
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1495
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS, INC.
- Date Received
- August 26, 2016
- Decision Date
- January 19, 2017
- Product Code
- JGJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JGJ | Photometric Method, Magnesium | FDA class 1 | Clinical Chemistry |
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