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FDA 510(k) Applications Submitted by SUE KENT
FDA 510(k) Number
Submission Date
Device Name
Applicant
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
K051433
06/01/2005
I-STAT CREATINE KINASE MB (CK-MB)
I-STAT CORPORATION
K053597
12/23/2005
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
I-STAT CORPORATION
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