FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
K Number: K142895
·
Decision May 21, 2015
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
25
Applicant Total
45
Review Days
230
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Basic Information
- Device Name
- LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
- K Number
- K142895
- 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
- October 3, 2014
- Decision Date
- May 21, 2015
- Product Code
- LTK
- 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 |
|---|---|---|---|
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | FDA class 2 | Immunology |
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