Abbott Architect Free T4
FDA 510(k) K173122 · Abbott Laboratories
510(k) numberK173122
Submission
- Device name
- Abbott Architect Free T4
- Applicant
- Abbott Laboratories
Abbot Park, IL, US - Received
- September 29, 2017
- Decision date
- October 27, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Abbott Architect Free T4 cleared by the FDA?
Abbott Architect Free T4 (K173122) received a 510(k) decision of Substantially Equivalent on October 27, 2017, 28 days after the submission was received.
What is the product code of K173122?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.