Access(R) Thyroxine Assay
FDA 510(k) K926475 · Bio-Rad Laboratories, Inc.
510(k) numberK926475
Submission
- Device name
- Access(R) Thyroxine Assay
- Applicant
- Bio-Rad Laboratories, Inc.
Chaska, MN, US - Received
- December 29, 1992
- Decision date
- June 15, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1700
- Specialty
- Clinical Chemistry
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Questions and answers
When was Access(R) Thyroxine Assay cleared by the FDA?
Access(R) Thyroxine Assay (K926475) received a 510(k) decision of Substantially Equivalent on June 15, 1993, 168 days after the submission was received.
What is the product code of K926475?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.