FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
K Number: K183375
·
Decision Feb 12, 2019
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
207
Applicant Total
1
Review Days
68
Basic Information
- Device Name
- Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
- K Number
- K183375
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Horiba, Ltd
- Date Received
- December 6, 2018
- Decision Date
- February 12, 2019
- Product Code
- JJE
- 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | FDA class 1 | Clinical Chemistry |
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