FDA 510(k) Applications Submitted by NANOSPHERE, INC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K083294 |
11/10/2008 |
VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST |
NANOSPHERE, INC |
| K092957 |
09/25/2009 |
VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST |
NANOSPHERE, INC |
| K093337 |
10/26/2009 |
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM |
NANOSPHERE, INC |
| K092566 |
08/20/2009 |
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) |
NANOSPHERE, INC |
| K083088 |
10/16/2008 |
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST |
NANOSPHERE, INC |
| K120466 |
02/15/2012 |
VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) |
NANOSPHERE, INC |
| DEN120014 |
06/15/2012 |
VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) |
NANOSPHERE, INC |
| K122514 |
08/17/2012 |
VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST |
NANOSPHERE, INC |
| K112424 |
08/23/2011 |
VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) |
NANOSPHERE, INC |
| K132843 |
09/10/2013 |
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) |
NANOSPHERE, INC |
| K123197 |
10/11/2012 |
VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) |
NANOSPHERE, INC |
| K143653 |
12/23/2014 |
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) |
NANOSPHERE, INC |
| K070597 |
03/02/2007 |
VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST |
NANOSPHERE, INC |
| K070804 |
03/23/2007 |
VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST |
NANOSPHERE, INC |
| K140083 |
01/13/2014 |
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) |
NANOSPHERE, INC |
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