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FDA 510(k)

PROSTATE-63 CANCER DIAGNOSTIC TEST

K-Number: K050063 · 2005-02-09

ApplicantAsymmetrx
Decision Date2005-02-09
Product CodeNTR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROSTATE-63 CANCER DIAGNOSTIC TEST is the device name listed in this FDA 510(k) record. The listed applicant is Asymmetrx. It received FDA 510(k) clearance on 2005-02-09 under 510(k) number K050063. The device is classified under product code NTR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTATE-63 CANCER DIAGNOSTIC TEST?

PROSTATE-63 CANCER DIAGNOSTIC TEST is a medical device that received FDA 510(k) clearance on 2005-02-09. The listed applicant is Asymmetrx. The 510(k) number is K050063.

When did PROSTATE-63 CANCER DIAGNOSTIC TEST receive FDA 510(k) clearance?

PROSTATE-63 CANCER DIAGNOSTIC TEST received FDA 510(k) clearance on 2005-02-09, under 510(k) number K050063.

Who is the listed applicant for PROSTATE-63 CANCER DIAGNOSTIC TEST?

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

What is the FDA product code for PROSTATE-63 CANCER DIAGNOSTIC TEST?

The FDA product code for PROSTATE-63 CANCER DIAGNOSTIC TEST is NTR.

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Official Source

View on FDA Database →

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

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