Radias Total T4 Enzyme Immunoassay
FDA 510(k) K946163 · Bio-Rad
510(k) numberK946163
Submission
- Device name
- Radias Total T4 Enzyme Immunoassay
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- December 19, 1994
- Decision date
- February 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K000600 | Syva Emit 2000 Thyroxine Assay, CalibratorsKLI · Traditional | Syva Co., Dade Behring, Inc. | 03/27/2000SE |
| K991432 | Biocheck Total T4 Enzyme Immunoassay Test Kit, Model BC-1007KLI · Traditional | Biocheck, Inc. | 06/02/1999SE |
| K982298 | Opticoat T4 Eia KitKLI · Traditional | Biotecx Laboratories, Inc. | 02/03/1999SE |
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Questions and answers
When was Radias Total T4 Enzyme Immunoassay cleared by the FDA?
Radias Total T4 Enzyme Immunoassay (K946163) received a 510(k) decision of Substantially Equivalent on February 22, 1995, 65 days after the submission was received.
What is the product code of K946163?
The FDA product code is KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.