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FDA 510(k)

URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A

K-Number: K033713 · 2004-02-09

ApplicantDade Behring, Inc.
Decision Date2004-02-09
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A 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 2004-02-09 under 510(k) number K033713. 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 URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A?

URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A is a medical device that received FDA 510(k) clearance on 2004-02-09. The listed applicant is Dade Behring, Inc.. The 510(k) number is K033713.

When did URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A receive FDA 510(k) clearance?

URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A received FDA 510(k) clearance on 2004-02-09, under 510(k) number K033713.

Who is the listed applicant for URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A?

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 URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A?

The FDA product code for URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A 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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