Advia Centaur FT4, Advia Centaur T4
FDA 510(k) K132249 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK132249
Submission
- Device name
- Advia Centaur FT4, Advia Centaur T4
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- July 19, 2013
- Decision date
- September 13, 2013
- 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 Advia Centaur FT4, Advia Centaur T4 cleared by the FDA?
Advia Centaur FT4, Advia Centaur T4 (K132249) received a 510(k) decision of Substantially Equivalent on September 13, 2013, 56 days after the submission was received.
What is the product code of K132249?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.