Access(R) Free T4 Assay
FDA 510(k) K925913 · Bio-Rad Laboratories, Inc.
510(k) numberK925913
Submission
- Device name
- Access(R) Free T4 Assay
- Applicant
- Bio-Rad Laboratories, Inc.
Chaska, MN, US - Received
- November 23, 1992
- Decision date
- January 27, 1993
- 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 Access(R) Free T4 Assay cleared by the FDA?
Access(R) Free T4 Assay (K925913) received a 510(k) decision of Substantially Equivalent on January 27, 1993, 65 days after the submission was received.
What is the product code of K925913?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.