Stratus(R) Total THYROXINE(T4) Fluor Enzyme Immuno
FDA 510(k) K933426 · Baxter Diagnostics, Inc.
510(k) numberK933426
Submission
- Device name
- Stratus(R) Total THYROXINE(T4) Fluor Enzyme Immuno
- Applicant
- Baxter Diagnostics, Inc.
Miami, FL, US - Received
- July 13, 1993
- Decision date
- August 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K922945 | Technicon Dax System Thyroxine (T4) MethodCDX · Traditional | Heraeus Kulzer, Inc. | 10/14/1992SE |
More from Heraeus Kulzer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934458 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 07/18/1995SE |
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| K935704 | Dried Gram-Negative Mic//Combo PanelsLTT · Traditional | 04/14/1995SE |
| K950570 | Stratus Progesterone Fluorometric Enzyme ImmunoassayJLS · Traditional | 04/11/1995SE |
| K945235 | Dried Gram-Positive Mic/Combo PanelsLTT · Traditional | 03/07/1995SE |
| K941030 | Dried Gram-Negative CefpodoximeLTT · Traditional | 02/16/1995SE |
| K940917 | Loracarbef Gram-Nagative PanelsJWY · Traditional | 02/08/1995SE |
| K941459 | Gram Positive Dried Overnight Panels/LomefloxJWY · Traditional | 02/03/1995SE |
| K941317 | Dried Gram Negative/CefmetazoleJWY · Traditional | 01/31/1995SE |
| K942267 | Dried Gram-Positive Mic/Combo Panels/CefmetazoleJWY · Traditional | 01/09/1995SE |
Questions and answers
When was Stratus(R) Total THYROXINE(T4) Fluor Enzyme Immuno cleared by the FDA?
Stratus(R) Total THYROXINE(T4) Fluor Enzyme Immuno (K933426) received a 510(k) decision of Substantially Equivalent on August 26, 1993, 44 days after the submission was received.
What is the product code of K933426?
The FDA product code is CDX – Radioimmunoassay, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.