FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Core Metabolic
K Number: K251157
·
Decision Jan 9, 2026
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
119
Applicant Total
4
Review Days
269
Basic Information
- Device Name
- Core Metabolic
- K Number
- K251157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Truvian Health
- Date Received
- April 15, 2025
- Decision Date
- January 9, 2026
- Product Code
- CIX
- 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 |
|---|---|---|---|
| CIX | Bromcresol Green Dye-Binding, Albumin | FDA class 2 | Clinical Chemistry |
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