FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lumipulse G whole PTH
K Number: K190702
·
Decision Aug 30, 2019
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
85
Applicant Total
45
Review Days
165
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Basic Information
- Device Name
- Lumipulse G whole PTH
- K Number
- K190702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1545
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujirebio Diagnostics,Inc.
- Date Received
- March 18, 2019
- Decision Date
- August 30, 2019
- Product Code
- CEW
- 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 |
|---|---|---|---|
| CEW | Radioimmunoassay, Parathyroid Hormone | FDA class 2 | Clinical Chemistry |
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LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
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·Clinical Chemistry
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