T4 Eia Bead Assay
FDA 510(k) K920766 · Tech-Co, Inc.
510(k) numberK920766
Submission
- Device name
- T4 Eia Bead Assay
- Applicant
- Tech-Co, Inc.
Rochester Hills, MI, US - Received
- February 19, 1992
- Decision date
- April 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CDX – Radioimmunoassay, Total Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1700
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961490 | Elecsys T4 AssayCDX · Traditional | Boehringer Mannheim Corp. | 06/13/1996SE |
| K954312 | Active Thyroxine RiaCDX · Traditional | Diagnostic Systems Laboratories, Inc. | 10/07/1995SE |
| K943416 | Delfia Neonatal Thyroxine KitCDX · Traditional | Wallac OY | 03/10/1995SE |
| K934384 | Axsym(Tm) Total T4CDX · Traditional | Abbott Laboratories | 06/21/1994SE |
| K932980 | Total T4 Fpia Reagent Set/Calibrator #T-1039,T-116CDX · Traditional | Sigma Diagnostics, Inc. | 10/18/1993SE |
| K933426 | Stratus(R) Total THYROXINE(T4) Fluor Enzyme ImmunoCDX · Traditional | Baxter Diagnostics, Inc. | 08/26/1993SE |
| K931295 | Iq TT4 AssayCDX · Traditional | Becton Dickinson Advanced Diagnostics | 07/20/1993SE |
| K926563 | Autobead(Tm) T4 Enzyme Immunoassay Test KitCDX · Traditional | Bio-Chem Laboratory Systems, Inc. | 03/18/1993SE |
| K925110 | Abbott Imx T4CDX · Traditional | Abbott Laboratories | 01/26/1993SE |
| K925109 | Abbott Tdx/Tdxflx TT4CDX · Traditional | Abbott Laboratories | 01/04/1993SE |
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| K902574 | Potassium Reagent SetCEJ · Traditional | 07/10/1990SE |
| K901561 | Iron/Total Iron Binding CapacityJIY · Traditional | 05/17/1990SE |
| K883387 | Alanine Amino Transferase (Colorimetric Method)CKD · Traditional | 10/13/1988SE |
| K883683 | HemoglobinGJZ · Traditional | 10/06/1988SE |
| K883386 | ChlorideCHJ · Traditional | 10/06/1988SE |
| K881173 | Aspartate Aminotransferase (Colorimetric Method)CIQ · Traditional | 06/07/1988SE |
| K881172 | Bilirubin (Direct)CIG · Traditional | 06/07/1988SE |
Questions and answers
When was T4 Eia Bead Assay cleared by the FDA?
T4 Eia Bead Assay (K920766) received a 510(k) decision of Substantially Equivalent on April 17, 1992, 58 days after the submission was received.
What is the product code of K920766?
The FDA product code is CDX – Radioimmunoassay, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.