URISCAN OPTIMA— 510(k) K141874
Substantially EquivalentYd Diagnostics Corp.
FDA 510(k) clearance K141874 for URISCAN OPTIMA, Substantially Equivalent on 2015-05-28. Applicant: Yd Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Yd Diagnostics Corp.
- Product code
- Code KQO
- Device class
- Class 1
- Regulation
- 21 CFR 862.2900
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gangnam-Gu, KR
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More clearances from Yd Diagnostics Corp.
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