URISCAN OPTIMA
FDA 510(k) clearance K141874 · decided 2015-05-28
Clearance details
- K-number
- K141874
- Device name
- URISCAN OPTIMA
- Applicant
- Yd Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-11
- Decision date
- 2015-05-28
- Days to decision
- 321 days
- Clearance type
- Traditional
- Product code
- KQO
- Device class
- 1
- Regulation number
- 862.2900
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Gangnam-Gu, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.