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FDA 510(k)

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

K-Number: K082150 · 2009-02-04

ApplicantPreanalytix GmbH
Decision Date2009-02-04
Product CodeNTW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Preanalytix GmbH. It received FDA 510(k) clearance on 2009-02-04 under 510(k) number K082150. The device is classified under product code NTW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO PAXGENE BLOOD RNA SYSTEM?

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM is a medical device that received FDA 510(k) clearance on 2009-02-04. The listed applicant is Preanalytix GmbH. The 510(k) number is K082150.

When did MODIFICATION TO PAXGENE BLOOD RNA SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM received FDA 510(k) clearance on 2009-02-04, under 510(k) number K082150.

Who is the listed applicant for MODIFICATION TO PAXGENE BLOOD RNA SYSTEM?

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

What is the FDA product code for MODIFICATION TO PAXGENE BLOOD RNA SYSTEM?

The FDA product code for MODIFICATION TO PAXGENE BLOOD RNA SYSTEM is NTW.

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Other records listing Preanalytix GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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