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FDA 510(k)

EMIT II PLUS ECSTASY ASSAY

K-Number: K043028 · 2005-01-07

ApplicantDade Behring, Inc.
Decision Date2005-01-07
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT II PLUS ECSTASY ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2005-01-07 under 510(k) number K043028. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT II PLUS ECSTASY ASSAY?

EMIT II PLUS ECSTASY ASSAY is a medical device that received FDA 510(k) clearance on 2005-01-07. The listed applicant is Dade Behring, Inc.. The 510(k) number is K043028.

When did EMIT II PLUS ECSTASY ASSAY receive FDA 510(k) clearance?

EMIT II PLUS ECSTASY ASSAY received FDA 510(k) clearance on 2005-01-07, under 510(k) number K043028.

Who is the listed applicant for EMIT II PLUS ECSTASY ASSAY?

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

What is the FDA product code for EMIT II PLUS ECSTASY ASSAY?

The FDA product code for EMIT II PLUS ECSTASY ASSAY is DKZ.

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Related Devices (Code: DKZ)

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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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