FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
K Number: K153361
·
Decision Apr 15, 2016
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
45
Applicant Total
45
Review Days
147
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Basic Information
- Device Name
- Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
- K Number
- K153361
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1825
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujirebio Diagnostics,Inc.
- Date Received
- November 20, 2015
- Decision Date
- April 15, 2016
- Product Code
- MRG
- 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 |
|---|---|---|---|
| MRG | System, Test, Vitamin D | FDA class 2 | Clinical Chemistry |
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