510(k) K070804— VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
Substantially EquivalentNanosphere, Inc.
Clearance details
- Applicant
- Nanosphere, Inc.
- Product code
- Code ODW
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northbrook, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.