FDA 510(k)

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

K-Number: K083294 · 2009-07-24

Decision Date2009-07-24

Product CodeNUA

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Nanosphere, Inc.. It received FDA 510(k) clearance on 2009-07-24 under 510(k) number K083294. The device is classified under product code NUA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST?

VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST is a medical device that received FDA 510(k) clearance on 2009-07-24. The listed applicant is Nanosphere, Inc.. The 510(k) number is K083294.

When did VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST receive FDA 510(k) clearance?

VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST received FDA 510(k) clearance on 2009-07-24, under 510(k) number K083294.

Who is the listed applicant for VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST?

The FDA 510(k) record lists Nanosphere, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST?

The FDA product code for VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST is NUA.

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Other records listing Nanosphere, Inc. as applicant

K123197VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)K120466VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)K122514VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST K112424VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)K103209VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)K093337VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM

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Related Devices (Code: NUA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.