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Nanosphere, Inc.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K123197 VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)OZN2012-12-05 View
510(k) K120466 VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)NTI2012-11-06 View
510(k) K122514 VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TESTPAM2012-09-19 View
510(k) K112424 VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)NQX2011-12-16 View
510(k) K103209 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)OCC2011-01-10 View
510(k) K093337 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEMOCC2009-11-17 View
510(k) K092957 VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TESTOCC2009-10-21 View
510(k) K092566 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)OCC2009-10-09 View
510(k) K083294 VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TESTNUA2009-07-24 View
510(k) K083088 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TESTOCC2009-05-01 View
510(k) K070597 VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TESTNSU2007-10-11 View
510(k) K070804 VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TESTODW2007-09-17 View
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