Axsym Free Thyroxine ( Free T4 )
FDA 510(k) K934544 · Abbott Laboratories
510(k) numberK934544
Submission
- Device name
- Axsym Free Thyroxine ( Free T4 )
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- September 22, 1993
- Decision date
- June 21, 1994
- 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 Axsym Free Thyroxine ( Free T4 ) cleared by the FDA?
Axsym Free Thyroxine ( Free T4 ) (K934544) received a 510(k) decision of Substantially Equivalent on June 21, 1994, 272 days after the submission was received.
What is the product code of K934544?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.