Vidas FT4
FDA 510(k) K132058 · Biomerieux S.A.
510(k) numberK132058
Submission
- Device name
- Vidas FT4
- Applicant
- Biomerieux S.A.
Craponne, FR - Received
- July 3, 2013
- Decision date
- June 8, 2015
- 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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| K173122 | Abbott Architect Free T4CEC · Special | Abbott Laboratories | 10/27/2017SE |
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| K140842 | Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid…CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/26/2014SE |
| K131244 | Elecsys FT4 II Assay, Elecsys FT4 II CalsetCEC · Traditional | Roche Diagnostics | 01/27/2014SE |
| K132249 | Advia Centaur FT4, Advia Centaur T4CEC · Traditional | Siemens Healthcare Diagnostics, Inc. | 09/13/2013SE |
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Questions and answers
When was Vidas FT4 cleared by the FDA?
Vidas FT4 (K132058) received a 510(k) decision of Substantially Equivalent on June 8, 2015, 705 days after the submission was received.
What is the product code of K132058?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.