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FDA 510(k)

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10

K-Number: K160829 · 2016-06-13

ApplicantMeridian Bioscience, Inc.
Decision Date2016-06-13
Product CodeOZX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 is a medical device manufactured by Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2016-06-13 under approval number K160829. The device is classified under product code OZX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10?

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 is a medical device that received FDA 510(k) clearance on 2016-06-13. It is manufactured by Meridian Bioscience, Inc.. The 510(k) number is K160829.

When was illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 approved by the FDA?

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 received FDA 510(k) clearance on 2016-06-13, under approval number K160829.

What company makes illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10?

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 is manufactured by Meridian Bioscience, Inc..

What is the FDA product code for illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10?

The FDA product code for illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 is OZX.

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Related PubMed Literature

PMID: 37288633 [Roadmap of Medical Device for Implanted Brain-computer Interface]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023)

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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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