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FDA 510(k)

CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY

K-Number: K904329 · 1991-03-12

ApplicantBaxter Healthcare Corp
Decision Date1991-03-12
Product CodeMCB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1991-03-12 under 510(k) number K904329. The device is classified under product code MCB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY?

CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1991-03-12. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K904329.

When did CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1991-03-12, under 510(k) number K904329.

Who is the listed applicant for CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY?

The FDA product code for CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY is MCB.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: MCB)

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.

K132010VIDAS C DIFFICILE GDHBiomerieux S.A.K112048IMMUNOCARD C. DIFFICILE GDHMeridian Bioscience, Inc.K110620PREMIER C. DIFFICILE GDHMeridian Bioscience, Inc.K053572C. DIFF QUIK CHEKTechlab, Inc.K974881TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN ABiosite IncorporatedK955067CLEARVIEW C. DIFF AUnipath , Ltd.

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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