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FDA 510(k)

ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT

K-Number: K112125 · 2011-12-05

ApplicantMeridian Bioscience, Inc.
Decision Date2011-12-05
Product CodeNJR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT 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 2011-12-05 under 510(k) number K112125. 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 ,EXTERNAL CONTROL KIT?

ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT is a medical device that received FDA 510(k) clearance on 2011-12-05. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K112125.

When did ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT receive FDA 510(k) clearance?

ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT received FDA 510(k) clearance on 2011-12-05, under 510(k) number K112125.

Who is the listed applicant for ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT?

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 ,EXTERNAL CONTROL KIT?

The FDA product code for ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT 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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