FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nova Allegro UACR Assay, Nova Allegro Analyzer
K Number: K252206
·
Decision Jan 9, 2026
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
40
Review Days
179
Basic Information
- Device Name
- Nova Allegro UACR Assay, Nova Allegro Analyzer
- K Number
- K252206
- Device Class
- FDA class 2
- Clearance Type
- Dual Track
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nova Biomedical Corporation
- Date Received
- July 14, 2025
- Decision Date
- January 9, 2026
- Product Code
- CGX
- 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | FDA class 2 | Clinical Chemistry |
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Other Clearances by Nova Biomedical Corporation
| K Number | Device Name | ||
|---|---|---|---|
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| K232075 | StatStrip Glucose Hospital Meter System | Feb 23, 2024 | Substantially Equivalent |
| K221900 | Stat Profile Prime Plus Analyzer System | Sep 29, 2023 | Substantially Equivalent |
| K203549 | Nova Primary Glucose Analyzer System | Oct 18, 2022 | Substantially Equivalent |
| K200403 | Stat Profile Prime Plus Analyzer System | Apr 14, 2020 | Substantially Equivalent |
| K200204 | Stat Profile Prime Plus Analyzer System | Apr 6, 2020 | Substantially Equivalent |
| K200349 | Stat Profile Prime Plus Analyzer System | Mar 13, 2020 | Substantially Equivalent |
| K193246 | Stat Profile Prime Plus Analyzer System | Jan 24, 2020 | Substantially Equivalent |