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FDA 510(k)

VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118

K-Number: K072138 · 2007-12-21

ApplicantbioMerieux, Inc.
Decision Date2007-12-21
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2007-12-21 under 510(k) number K072138. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118?

VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 is a medical device that received FDA 510(k) clearance on 2007-12-21. The listed applicant is bioMerieux, Inc.. The 510(k) number is K072138.

When did VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 receive FDA 510(k) clearance?

VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 received FDA 510(k) clearance on 2007-12-21, under 510(k) number K072138.

Who is the listed applicant for VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118?

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

What is the FDA product code for VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118?

The FDA product code for VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 is LLH.

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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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