Elecsys FT4 II Assay, Elecsys FT4 II Calset
FDA 510(k) K131244 · Roche Diagnostics
510(k) numberK131244
Submission
- Device name
- Elecsys FT4 II Assay, Elecsys FT4 II Calset
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- May 1, 2013
- Decision date
- January 27, 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 Elecsys FT4 II Assay, Elecsys FT4 II Calset cleared by the FDA?
Elecsys FT4 II Assay, Elecsys FT4 II Calset (K131244) received a 510(k) decision of Substantially Equivalent on January 27, 2014, 271 days after the submission was received.
What is the product code of K131244?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.