FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Stat Profile Prime Plus Analyzer System
K Number: K221900
·
Decision Sep 29, 2023
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
187
Applicant Total
40
Review Days
456
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Basic Information
- Device Name
- Stat Profile Prime Plus Analyzer System
- K Number
- K221900
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nova Biomedical Corporation
- Date Received
- June 30, 2022
- Decision Date
- September 29, 2023
- Product Code
- CHL
- 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | FDA class 2 | Clinical Chemistry |
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