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FDA 510(k)

STREPTOCOCCUS APP. SEROLOGICAL REAGENTS

K-Number: K122019 · 2012-09-13

ApplicantMeridian Bioscience, Inc.
Decision Date2012-09-13
Product CodeOYZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREPTOCOCCUS APP. SEROLOGICAL REAGENTS 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 2012-09-13 under 510(k) number K122019. The device is classified under product code OYZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STREPTOCOCCUS APP. SEROLOGICAL REAGENTS?

STREPTOCOCCUS APP. SEROLOGICAL REAGENTS is a medical device that received FDA 510(k) clearance on 2012-09-13. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K122019.

When did STREPTOCOCCUS APP. SEROLOGICAL REAGENTS receive FDA 510(k) clearance?

STREPTOCOCCUS APP. SEROLOGICAL REAGENTS received FDA 510(k) clearance on 2012-09-13, under 510(k) number K122019.

Who is the listed applicant for STREPTOCOCCUS APP. SEROLOGICAL REAGENTS?

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 STREPTOCOCCUS APP. SEROLOGICAL REAGENTS?

The FDA product code for STREPTOCOCCUS APP. SEROLOGICAL REAGENTS is OYZ.

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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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