Phase Thyroxine Radioimmunoassay Kit
FDA 510(k) K830642 · Medical & Scientific Designs, Inc.
510(k) numberK830642
Submission
- Device name
- Phase Thyroxine Radioimmunoassay Kit
- Applicant
- Medical & Scientific Designs, Inc.
Mchenry, IL, US - Received
- March 1, 1983
- Decision date
- April 5, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K862960 | Phase II Ferritin Radioimmunoassay KitDBF · Traditional | 08/27/1986SE |
| K853224 | Phase II B-12/FOLATE KitCDD · Traditional | 10/03/1985SE |
| K840901 | Phase II Free T4 KitCEC · Traditional | 04/25/1984SE |
| K840328 | Phase II HCG KitJHI · Traditional | 04/19/1984SE |
| K834219 | Phase II Cortisol KitCGR · Traditional | 02/04/1984SE |
| K833789 | Phase II Theophylline RadioimmunoassayLCA · Traditional | 01/24/1984SE |
| K832499 | Phase II TSH KitJLW · Traditional | 09/12/1983SE |
| K832210 | Gamma Photon Gamma CounterJJJ · Traditional | 08/24/1983SE |
| K832209 | Kineti Count 24 Gamma CounterJJJ · Traditional | 08/24/1983SE |
| K831064 | Phase II T3 Radioimmunoassay KitCDP · Traditional | 05/09/1983SE |
Questions and answers
When was Phase Thyroxine Radioimmunoassay Kit cleared by the FDA?
Phase Thyroxine Radioimmunoassay Kit (K830642) received a 510(k) decision of Substantially Equivalent on April 5, 1983, 35 days after the submission was received.
What is the product code of K830642?
The FDA product code is CDX – Radioimmunoassay, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.