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FDA 510(k)

IMMUNOCARD STAT! FLU A & B

K-Number: K041626 · 2005-03-16

ApplicantMeridian Bioscience, Inc.
Decision Date2005-03-16
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOCARD STAT! FLU A & B 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 2005-03-16 under 510(k) number K041626. 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 IMMUNOCARD STAT! FLU A & B?

IMMUNOCARD STAT! FLU A & B is a medical device that received FDA 510(k) clearance on 2005-03-16. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K041626.

When did IMMUNOCARD STAT! FLU A & B receive FDA 510(k) clearance?

IMMUNOCARD STAT! FLU A & B received FDA 510(k) clearance on 2005-03-16, under 510(k) number K041626.

Who is the listed applicant for IMMUNOCARD STAT! FLU A & B?

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 IMMUNOCARD STAT! FLU A & B?

The FDA product code for IMMUNOCARD STAT! FLU A & B is PSZ.

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Related Devices (Code: 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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