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FDA 510(k) Applications Submitted by GREGORY W SHIPP
FDA 510(k) Number
Submission Date
Device Name
Applicant
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
K031739
06/04/2003
I-STAT CARDIAC TROPONIN (CTNI) TEST
I-STAT CORPORATION
K031873
06/17/2003
I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET
I-STAT CORPORATION
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
K103209
11/01/2010
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
NANOSPHERE, INC.
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