FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
K Number: K221197
·
Decision Sep 5, 2023
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
85
Applicant Total
14
Review Days
498
Basic Information
- Device Name
- VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
- K Number
- K221197
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1545
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Clinical Diagnostics
- Date Received
- April 25, 2022
- Decision Date
- September 5, 2023
- 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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