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FDA 510(k)

CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-

K-Number: K833447 · 1984-05-21

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1984-05-21
Product CodeMCB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- is the device name listed in this FDA 510(k) record. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. It received FDA 510(k) clearance on 1984-05-21 under 510(k) number K833447. 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 CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-?

CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- is a medical device that received FDA 510(k) clearance on 1984-05-21. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K833447.

When did CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- receive FDA 510(k) clearance?

CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- received FDA 510(k) clearance on 1984-05-21, under 510(k) number K833447.

Who is the listed applicant for CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-?

The FDA 510(k) record lists Bartels Immunodiagnostic Supplies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-?

The FDA product code for CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- is MCB.

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Other records listing Bartels Immunodiagnostic Supplies, Inc. 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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