FDA 510(k)

DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109

K-Number: K053337 · 2006-05-19

Decision Date2006-05-19

Product CodeDKZ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 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 2006-05-19 under 510(k) number K053337. 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 DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109?

DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 is a medical device that received FDA 510(k) clearance on 2006-05-19. The listed applicant is Dade Behring, Inc.. The 510(k) number is K053337.

When did DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 receive FDA 510(k) clearance?

DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 received FDA 510(k) clearance on 2006-05-19, under 510(k) number K053337.

Who is the listed applicant for DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109?

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 DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109?

The FDA product code for DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 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.