FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Healgen® URS Test Strips
K Number: K251800
·
Decision Dec 23, 2025
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
12
Applicant Total
27
Review Days
194
Basic Information
- Device Name
- Healgen® URS Test Strips
- K Number
- K251800
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1510
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healgen Scientific,, LLC
- Date Received
- June 12, 2025
- Decision Date
- December 23, 2025
- Product Code
- JMT
- 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 |
|---|---|---|---|
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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