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FDA 510(k)

EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY

K-Number: K020441 · 2002-03-28

ApplicantDade Behring, Inc.
Decision Date2002-03-28
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT II PLUS MONOCLONAL COCAINE METABOLITE 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 2002-03-28 under 510(k) number K020441. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY?

EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY is a medical device that received FDA 510(k) clearance on 2002-03-28. The listed applicant is Dade Behring, Inc.. The 510(k) number is K020441.

When did EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY receive FDA 510(k) clearance?

EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY received FDA 510(k) clearance on 2002-03-28, under 510(k) number K020441.

Who is the listed applicant for EMIT II PLUS MONOCLONAL COCAINE METABOLITE 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 MONOCLONAL COCAINE METABOLITE ASSAY?

The FDA product code for EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY is DIO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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