VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)— 510(k) K092566
Substantially EquivalentNanosphere, Inc.
FDA 510(k) clearance K092566 for VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP), Substantially Equivalent on 2009-10-09. Applicant: Nanosphere, Inc.. Device class: 2.
Clearance details
- Applicant
- Nanosphere, Inc.
- Product code
- Code OCC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northbrook, IL, US
Recent devices under product code OCC
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- K140083 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
- K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
- K123197 — VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
- K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
Adverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.