Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module
FDA 510(k) K043546 · Dade Behring, Inc.
510(k) numberK043546
Submission
- Device name
- Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- December 23, 2004
- Decision date
- January 18, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1705
- Specialty
- Clinical Chemistry
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Questions and answers
When was Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module cleared by the FDA?
Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module (K043546) received a 510(k) decision of Substantially Equivalent on January 18, 2005, 26 days after the submission was received.
What is the product code of K043546?
The FDA product code is CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, a Class I (low risk) device regulated under 21 CFR 862.1705.