VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST— 510(k) K070804
Substantially EquivalentNanosphere, Inc.
FDA 510(k) clearance K070804 for VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST, Substantially Equivalent on 2007-09-17. Applicant: Nanosphere, Inc.. Device class: 2.
Clearance details
- Applicant
- Nanosphere, Inc.
- 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
- Northbrook, IL, US
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