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FDA 510(k)

AMPLIVUE C. DIFFICILE ASSAY

K-Number: K123355 · 2012-12-13

ApplicantQuidel Corporation
Decision Date2012-12-13
Product CodeOZN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMPLIVUE C. DIFFICILE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2012-12-13 under 510(k) number K123355. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMPLIVUE C. DIFFICILE ASSAY?

AMPLIVUE C. DIFFICILE ASSAY is a medical device that received FDA 510(k) clearance on 2012-12-13. The listed applicant is Quidel Corporation. The 510(k) number is K123355.

When did AMPLIVUE C. DIFFICILE ASSAY receive FDA 510(k) clearance?

AMPLIVUE C. DIFFICILE ASSAY received FDA 510(k) clearance on 2012-12-13, under 510(k) number K123355.

Who is the listed applicant for AMPLIVUE C. DIFFICILE ASSAY?

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

What is the FDA product code for AMPLIVUE C. DIFFICILE ASSAY?

The FDA product code for AMPLIVUE C. DIFFICILE ASSAY is OZN.

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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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