Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid Stimulating Hormone Flex Reagent
FDA 510(k) K140859 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK140859
Submission
- Device name
- Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid Stimulating Hormone Flex Reagent
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Newark, DE, US - Received
- April 3, 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 Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid Stimulating Hormone Flex Reagent cleared by the FDA?
Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid Stimulating Hormone Flex Reagent (K140859) received a 510(k) decision of Substantially Equivalent on November 26, 2014, 237 days after the submission was received.
What is the product code of K140859?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.