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FDA 510(k)

ARTUS INFL A/B RG RT-PCR KIT

K-Number: K113323 · 2012-02-06

ApplicantQIAGEN GmbH
Decision Date2012-02-06
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ARTUS INFL A/B RG RT-PCR KIT 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 K113323. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTUS INFL A/B RG RT-PCR KIT?

ARTUS INFL A/B RG RT-PCR KIT 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 K113323.

When did ARTUS INFL A/B RG RT-PCR KIT receive FDA 510(k) clearance?

ARTUS INFL A/B RG RT-PCR KIT received FDA 510(k) clearance on 2012-02-06, under 510(k) number K113323.

Who is the listed applicant for ARTUS INFL A/B RG RT-PCR KIT?

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 ARTUS INFL A/B RG RT-PCR KIT?

The FDA product code for ARTUS INFL A/B RG RT-PCR KIT is OCC.

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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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