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FDA 510(k)

TRU FLU, MODEL 751230

K-Number: K092553 · 2009-09-11

ApplicantMeridian Bioscience, Inc.
Decision Date2009-09-11
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TRU FLU, MODEL 751230 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 2009-09-11 under 510(k) number K092553. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRU FLU, MODEL 751230?

TRU FLU, MODEL 751230 is a medical device that received FDA 510(k) clearance on 2009-09-11. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K092553.

When did TRU FLU, MODEL 751230 receive FDA 510(k) clearance?

TRU FLU, MODEL 751230 received FDA 510(k) clearance on 2009-09-11, under 510(k) number K092553.

Who is the listed applicant for TRU FLU, MODEL 751230?

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 TRU FLU, MODEL 751230?

The FDA product code for TRU FLU, MODEL 751230 is PSZ.

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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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