FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lumpipulse G CA19-9-N
K Number: K191973
·
Decision Oct 22, 2019
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
10
Applicant Total
1
Review Days
90
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Basic Information
- Device Name
- Lumpipulse G CA19-9-N
- K Number
- K191973
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujirebio Dianostics, Inc.
- Date Received
- July 24, 2019
- Decision Date
- October 22, 2019
- Product Code
- NIG
- 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 |
|---|---|---|---|
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | FDA class 2 | Immunology |
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