DISINTEK™ PA Test Strips
FDA 510(k) clearance K251035 · decided 2025-06-03
Clearance details
- K-number
- K251035
- Device name
- DISINTEK™ PA Test Strips
- Applicant
- Serim Research
- Decision
- Substantially Equivalent
- Date received
- 2025-04-03
- Decision date
- 2025-06-03
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Elkhart, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.