DISINTEK PA Test Strips— 510(k) K251035
Substantially EquivalentSerim Research
FDA 510(k) clearance K251035 for DISINTEK PA Test Strips, Substantially Equivalent on 2025-06-03. Applicant: Serim Research. Device class: 2.
Clearance details
- Applicant
- Serim Research
- Product code
- Code JOJ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
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More clearances from Serim Research
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