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FDA 510(k)

SYVA EMIT II PLUS AMPHETAMINES ASSAY

K-Number: K031004 · 2003-06-06

ApplicantDade Behring, Inc.
Decision Date2003-06-06
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYVA EMIT II PLUS AMPHETAMINES 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 2003-06-06 under 510(k) number K031004. 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 SYVA EMIT II PLUS AMPHETAMINES ASSAY?

SYVA EMIT II PLUS AMPHETAMINES ASSAY is a medical device that received FDA 510(k) clearance on 2003-06-06. The listed applicant is Dade Behring, Inc.. The 510(k) number is K031004.

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

SYVA EMIT II PLUS AMPHETAMINES ASSAY received FDA 510(k) clearance on 2003-06-06, under 510(k) number K031004.

Who is the listed applicant for SYVA EMIT II PLUS AMPHETAMINES 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 SYVA EMIT II PLUS AMPHETAMINES ASSAY?

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

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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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