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FDA 510(k)

ROTOR-GENE Q MDX

K-Number: K113319 · 2012-02-06

ApplicantQIAGEN GmbH
Decision Date2012-02-06
Product CodeOOI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROTOR-GENE Q MDX is the device name listed in this FDA 510(k) record. The listed applicant is QIAGEN GmbH. It received FDA 510(k) clearance on 2012-02-06 under 510(k) number K113319. The device is classified under product code OOI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTOR-GENE Q MDX?

ROTOR-GENE Q MDX is a medical device that received FDA 510(k) clearance on 2012-02-06. The listed applicant is QIAGEN GmbH. The 510(k) number is K113319.

When did ROTOR-GENE Q MDX receive FDA 510(k) clearance?

ROTOR-GENE Q MDX received FDA 510(k) clearance on 2012-02-06, under 510(k) number K113319.

Who is the listed applicant for ROTOR-GENE Q MDX?

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

What is the FDA product code for ROTOR-GENE Q MDX?

The FDA product code for ROTOR-GENE Q MDX is OOI.

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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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