VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)— 510(k) K112424
Substantially EquivalentNanosphere, Inc.
FDA 510(k) clearance K112424 for VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S), Substantially Equivalent on 2011-12-16. Applicant: Nanosphere, Inc.. Device class: 2.
Clearance details
- Applicant
- Nanosphere, Inc.
- Product code
- Code NQX
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northbrook, IL, US
Recent devices under product code NQX
view allMore clearances from Nanosphere, Inc.
view all- K143653 — Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.