FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lumipulse G CA15-3
K Number: K192524
·
Decision Sep 4, 2020
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
27
Applicant Total
45
Review Days
357
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Basic Information
- Device Name
- Lumipulse G CA15-3
- K Number
- K192524
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujirebio Diagnostics,Inc.
- Date Received
- September 13, 2019
- Decision Date
- September 4, 2020
- Product Code
- MOI
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| MOI | System, Test, Immunological, Antigen, Tumor | FDA class 2 | Immunology |
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