Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod
FDA 510(k) K073604 · Dade Behring, Inc.
510(k) numberK073604
Submission
- Device name
- Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- December 21, 2007
- Decision date
- March 13, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEC – Radioimmunoassay, Free Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1695
- Specialty
- Clinical Chemistry
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Questions and answers
When was Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod cleared by the FDA?
Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod (K073604) received a 510(k) decision of Substantially Equivalent on March 13, 2008, 83 days after the submission was received.
What is the product code of K073604?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.