ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT— 510(k) K073720
Substantially EquivalentOsmetech Molecular Diagnostics
FDA 510(k) clearance K073720 for ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT, Substantially Equivalent on 2008-07-17. Applicant: Osmetech Molecular Diagnostics. Device class: 2.
Clearance details
- Applicant
- Osmetech Molecular Diagnostics
- Product code
- Code ODW
- Device class
- Class 2
- Regulation
- 21 CFR 862.3360
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pasadena, CA, US
Recent devices under product code ODW
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