FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lumipulse G TSH-III Immunoreaction Cartridges
K Number: K171103
·
Decision Jul 28, 2017
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
45
Review Days
106
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Basic Information
- Device Name
- Lumipulse G TSH-III Immunoreaction Cartridges
- K Number
- K171103
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujirebio Diagnostics,Inc.
- Date Received
- April 13, 2017
- Decision Date
- July 28, 2017
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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