Medical Device Manufacturer · US , Northbrook , IL

Nanosphere, Inc. - FDA 510(k) Cleared Devices

16 submissions · 15 cleared · Since 2007

Recent clearances: Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex), VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP), VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)

16

Total

15

Cleared

1

Denied

FDA 510(k) Regulatory Record - Nanosphere, Inc. Pathology ✕

1 devices

1-1 of 1

Cleared Jul 24, 2009

VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST

Pathology · 256d