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FDA 510(k)

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

K-Number: K101185 · 2011-09-20

ApplicantIris Molecular Diagnostics
Decision Date2011-09-20
Product CodeOWM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Iris Molecular Diagnostics. It received FDA 510(k) clearance on 2011-09-20 under 510(k) number K101185. The device is classified under product code OWM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY?

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY is a medical device that received FDA 510(k) clearance on 2011-09-20. The listed applicant is Iris Molecular Diagnostics. The 510(k) number is K101185.

When did NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY receive FDA 510(k) clearance?

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY received FDA 510(k) clearance on 2011-09-20, under 510(k) number K101185.

Who is the listed applicant for NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY?

The FDA 510(k) record lists Iris Molecular Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY?

The FDA product code for NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY is OWM.

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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.

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