Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109
FDA 510(k) K053337 · Dade Behring, Inc.
510(k) numberK053337
Submission
- Device name
- Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- December 1, 2005
- Decision date
- May 19, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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Questions and answers
When was Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109 cleared by the FDA?
Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109 (K053337) received a 510(k) decision of Substantially Equivalent on May 19, 2006, 169 days after the submission was received.
What is the product code of K053337?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.