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FDA 510(k)

IMMUNOCARD STAT CAMPY, MODEL 751530

K-Number: K090700 · 2009-05-28

ApplicantMeridian Bioscience, Inc.
Decision Date2009-05-28
Product CodeLQP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOCARD STAT CAMPY, MODEL 751530 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 2009-05-28 under 510(k) number K090700. The device is classified under product code LQP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOCARD STAT CAMPY, MODEL 751530?

IMMUNOCARD STAT CAMPY, MODEL 751530 is a medical device that received FDA 510(k) clearance on 2009-05-28. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K090700.

When did IMMUNOCARD STAT CAMPY, MODEL 751530 receive FDA 510(k) clearance?

IMMUNOCARD STAT CAMPY, MODEL 751530 received FDA 510(k) clearance on 2009-05-28, under 510(k) number K090700.

Who is the listed applicant for IMMUNOCARD STAT CAMPY, MODEL 751530?

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 CAMPY, MODEL 751530?

The FDA product code for IMMUNOCARD STAT CAMPY, MODEL 751530 is LQP.

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Other records listing Meridian Bioscience, Inc. as applicant

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Related Devices (Code: LQP)

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.

K210976Curian CampyMeridian Bioscience, Inc.K211342Sofia 2 Campylobacter FIAQuidel CorporationK191456Campylobacter Quik ChekTechlab, Inc.K191442Campylobacter ChekTechlab, Inc.K173217CAMPYLOBACTER QUIK CHEKTechlab, Inc.K173219CAMPYLOBACTER CHEKTechlab, Inc.

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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