Radias Free T4 Enzyme Immunoassay
FDA 510(k) K931110 · Bio-Rad
510(k) numberK931110
Submission
- Device name
- Radias Free T4 Enzyme Immunoassay
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- March 3, 1993
- Decision date
- May 20, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Radias Free T4 Enzyme Immunoassay cleared by the FDA?
Radias Free T4 Enzyme Immunoassay (K931110) received a 510(k) decision of Substantially Equivalent on May 20, 1993, 78 days after the submission was received.
What is the product code of K931110?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.