Ria Kit, Neonatal T4
FDA 510(k) K782103 · Serono Laboratories, Inc.
510(k) numberK782103
Submission
- Device name
- Ria Kit, Neonatal T4
- Applicant
- Serono Laboratories, Inc.
Mchenry, IL, US - Received
- December 15, 1978
- Decision date
- January 17, 1979
- 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 |
|---|---|---|
| K834428 | Aldosterone Radioimmunoassay Test KitCJM · Traditional | 03/02/1984SE |
| K810695 | Estriol Radioimmunoassay Test KitCHP · Traditional | 03/31/1981SE |
| K810625 | Human Placental Lactogen Radioimmuno-DHI · Traditional | 03/27/1981SE |
| K792043 | Pap-Check Ria KitJFH · Traditional | 10/30/1979SE |
| K790679 | Estradiol Ria KitCHP · Traditional | 05/23/1979SE |
| K790440 | ProgesteroneJLS · Traditional | 05/03/1979SE |
| K782143 | Ria Kit, GlucoseJME · Traditional | 02/22/1979SE |
| K781733 | Ria Kit, Preg-StatJHI · Traditional | 12/20/1978SE |
| K781285 | Insulin Ria KitCFP · Traditional | 08/14/1978SE |
Questions and answers
When was Ria Kit, Neonatal T4 cleared by the FDA?
Ria Kit, Neonatal T4 (K782103) received a 510(k) decision of Substantially Equivalent on January 17, 1979, 33 days after the submission was received.
What is the product code of K782103?
The FDA product code is CDX – Radioimmunoassay, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.