Vista Free Thyroxine Assay
FDA 510(k) K923572 · Syva Co.
510(k) numberK923572
Submission
- Device name
- Vista Free Thyroxine Assay
- Applicant
- Syva Co.
San Jose, CA, US - Received
- July 17, 1992
- Decision date
- November 16, 1992
- 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 Vista Free Thyroxine Assay cleared by the FDA?
Vista Free Thyroxine Assay (K923572) received a 510(k) decision of Substantially Equivalent on November 16, 1992, 122 days after the submission was received.
What is the product code of K923572?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.