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FDA 510(k)

IMMUNOCARD STAT! RSV MODEL #750630

K-Number: K041445 · 2004-08-13

ApplicantMeridian Bioscience, Inc.
Decision Date2004-08-13
Product CodeGQG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOCARD STAT! RSV MODEL #750630 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 2004-08-13 under 510(k) number K041445. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOCARD STAT! RSV MODEL #750630?

IMMUNOCARD STAT! RSV MODEL #750630 is a medical device that received FDA 510(k) clearance on 2004-08-13. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K041445.

When did IMMUNOCARD STAT! RSV MODEL #750630 receive FDA 510(k) clearance?

IMMUNOCARD STAT! RSV MODEL #750630 received FDA 510(k) clearance on 2004-08-13, under 510(k) number K041445.

Who is the listed applicant for IMMUNOCARD STAT! RSV MODEL #750630?

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! RSV MODEL #750630?

The FDA product code for IMMUNOCARD STAT! RSV MODEL #750630 is GQG.

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Related Devices (Code: GQG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253318Clungene RSV Antigen Rapid TestHangzhou Clongene Biotech Co., Ltd.K240280Nano-Check™ RSV TestNano-Ditech CorporationK162911Sofia RSV FIA on Sofia 2 analyzerQuidel CorporationK133140BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSVBecton, Dickinson & COK132456BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSVBecton, Dickinson and CompanyK130398SOFIA(R) RSV FIAQuidel Corp.

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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