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FDA 510(k)

URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A

K-Number: K003209 · 2000-12-05

ApplicantDade Behring, Inc.
Decision Date2000-12-05
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A 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 2000-12-05 under 510(k) number K003209. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A?

URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A is a medical device that received FDA 510(k) clearance on 2000-12-05. The listed applicant is Dade Behring, Inc.. The 510(k) number is K003209.

When did URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A receive FDA 510(k) clearance?

URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A received FDA 510(k) clearance on 2000-12-05, under 510(k) number K003209.

Who is the listed applicant for URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A?

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 OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A?

The FDA product code for URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A is DJG.

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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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