Elecsys FT4 III
FDA 510(k) K181233 · Roche Diagnostics
510(k) numberK181233
Submission
- Device name
- Elecsys FT4 III
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- May 9, 2018
- Decision date
- September 18, 2018
- 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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| K131244 | Elecsys FT4 II Assay, Elecsys FT4 II CalsetCEC · Traditional | Roche Diagnostics | 01/27/2014SE |
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Questions and answers
When was Elecsys FT4 III cleared by the FDA?
Elecsys FT4 III (K181233) received a 510(k) decision of Substantially Equivalent on September 18, 2018, 132 days after the submission was received.
What is the product code of K181233?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.