FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Stat Profile Prime ES Comp Plus Analyzer System
K Number: K191626
·
Decision Aug 16, 2019
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
28
Applicant Total
40
Review Days
59
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Basic Information
- Device Name
- Stat Profile Prime ES Comp Plus Analyzer System
- K Number
- K191626
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nova Biomedical Corporation
- Date Received
- June 18, 2019
- Decision Date
- August 16, 2019
- Product Code
- JFP
- 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 |
|---|---|---|---|
| JFP | Electrode, Ion Specific, Calcium | FDA class 2 | Clinical Chemistry |
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