Healgen® URS Test Strips— 510(k) K251800
Substantially EquivalentHealgen Scientific,, LLC
FDA 510(k) clearance K251800 for Healgen® URS Test Strips, Substantially Equivalent on 2025-12-23. Applicant: Healgen Scientific,, LLC. Device class: 1.
Clearance details
- Applicant
- Healgen Scientific,, LLC
- Product code
- Code JMT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1510
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Recent devices under product code JMT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.