Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid Stimulating Hormone Flex Reagent Cart
FDA 510(k) K140842 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK140842
Submission
- Device name
- Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid Stimulating Hormone Flex Reagent Cart
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Newark, DE, US - Received
- April 2, 2014
- Decision date
- November 26, 2014
- 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 Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid Stimulating Hormone Flex Reagent Cart cleared by the FDA?
Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid Stimulating Hormone Flex Reagent Cart (K140842) received a 510(k) decision of Substantially Equivalent on November 26, 2014, 238 days after the submission was received.
What is the product code of K140842?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.