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FDA 510(k)

ENZYME-LINKED FLUORESCENT IMMUNOASSAY

K-Number: K943811 · 1994-11-02

ApplicantBiomerieux Vitek, Inc.
Decision Date1994-11-02
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYME-LINKED FLUORESCENT IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1994-11-02 under 510(k) number K943811. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYME-LINKED FLUORESCENT IMMUNOASSAY?

ENZYME-LINKED FLUORESCENT IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1994-11-02. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K943811.

When did ENZYME-LINKED FLUORESCENT IMMUNOASSAY receive FDA 510(k) clearance?

ENZYME-LINKED FLUORESCENT IMMUNOASSAY received FDA 510(k) clearance on 1994-11-02, under 510(k) number K943811.

Who is the listed applicant for ENZYME-LINKED FLUORESCENT IMMUNOASSAY?

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

What is the FDA product code for ENZYME-LINKED FLUORESCENT IMMUNOASSAY?

The FDA product code for ENZYME-LINKED FLUORESCENT IMMUNOASSAY is CFT.

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Other records listing Biomerieux Vitek, Inc. as applicant

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Related Devices (Code: CFT)

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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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