FDA 510(k) Applications Submitted by MARK A DEL VECCHIO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K990023 |
01/05/1999 |
HYBRID CAPTURE II CT-ID TEST |
DIGENE CORP. |
| 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 |
| K010891 |
03/26/2001 |
MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 |
DIGENE CORP. |
| K010892 |
03/26/2001 |
MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 |
DIGENE CORP. |
| K010893 |
03/26/2001 |
MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 |
DIGENE CORP. |
| K981485 |
04/24/1998 |
HYBRID CAPTURE II GC-ID |
DIGENE CORP. |
| K981567 |
05/01/1998 |
HYBRID CAPTURE II CT/GC TEST |
DIGENE CORP. |
| K063841 |
12/26/2006 |
NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS |
LIPOSCIENCE |
|
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