UBAS— 510(k) K993941
Substantially EquivalentMarukin Diagnostics
FDA 510(k) clearance K993941 for UBAS, Substantially Equivalent on 2000-03-02. Applicant: Marukin Diagnostics. Device class: 2.
Clearance details
- Applicant
- Marukin Diagnostics
- Product code
- Code KWX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1187
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code KWX
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