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FDA 510(k)

ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM

K-Number: K121044 · 2012-05-01

ApplicantMeridian Bioscience, Inc.
Decision Date2012-05-01
Product CodeNJR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2012-05-01 under 510(k) number K121044. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM?

ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM is a medical device that received FDA 510(k) clearance on 2012-05-01. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K121044.

When did ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM receive FDA 510(k) clearance?

ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM received FDA 510(k) clearance on 2012-05-01, under 510(k) number K121044.

Who is the listed applicant for ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM?

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

What is the FDA product code for ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM?

The FDA product code for ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM is NJR.

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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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