Iq TT4 Assay
FDA 510(k) K931295 · Becton Dickinson Advanced Diagnostics
510(k) numberK931295
Submission
- Device name
- Iq TT4 Assay
- Applicant
- Becton Dickinson Advanced Diagnostics
Sparks, MD, US - Received
- March 15, 1993
- Decision date
- July 20, 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 |
| K933426 | Stratus(R) Total THYROXINE(T4) Fluor Enzyme ImmunoCDX · Traditional | Baxter Diagnostics, Inc. | 08/26/1993SE |
| 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 |
|---|---|---|
| K935667 | Qtest(R) StrepGTY · Traditional | 04/21/1994SE |
| K931294 | Iq Tuptake AssayKHQ · Traditional | 07/22/1993SE |
| K926356 | Precise(Tm) Hcg(Urine/Serum) and Prcise(Tm) PregJHI · Traditional | 03/18/1993SE |
| K925132 | Becton Dickinson Thyroid Stimulating Hormone SysteJLW · Traditional | 12/28/1992SE |
| K923673 | Precise Strep aGTZ · Traditional | 09/28/1992SE |
| K923060 | Iq Immunochemistry Sistem; Iq TSH AssayJJE · Traditional | 09/15/1992SE |
| K914958 | Riatrac PlusJJY · Traditional | 03/18/1992SE |
| K915197 | Precise TM HCGJHI · Traditional | 12/17/1991SE |
| K915200 | Precise TM HCG for Use in the Physicians Office laJHI · Traditional | 12/16/1991SE |
Questions and answers
When was Iq TT4 Assay cleared by the FDA?
Iq TT4 Assay (K931295) received a 510(k) decision of Substantially Equivalent on July 20, 1993, 127 days after the submission was received.
What is the product code of K931295?
The FDA product code is CDX – Radioimmunoassay, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.