Ria Kit, Gammacoat
FDA 510(k) K782109 · Clinical Assays, Inc.
510(k) numberK782109
Submission
- Device name
- Ria Kit, Gammacoat
- Applicant
- Clinical Assays, Inc.
Walker, MI, US - Received
- December 19, 1978
- Decision date
- January 26, 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 |
|---|---|---|
| K832712 | Folate Radioassay Kit CA-1562-125CGN · Traditional | 10/04/1983SE |
| K832711 | Vitamin B12 Folate CA-1515-125CDD · Traditional | 10/04/1983SE |
| K832710 | Vitamin B12 Radioassay Kit CA-1534CDD · Traditional | 10/04/1983SE |
| K823476 | Gammadab LH Radio-Kit #CA-1508CEP · Traditional | 12/28/1982SE |
| K823313 | In Vitro Gammacoat B-Hcg Radio. TestJHI · Traditional | 12/22/1982SE |
| K821611 | Gammadab [125] FSH Radioimmunay KitCGJ · Traditional | 06/24/1982SE |
| K821092 | GAMMADAB[125]EGE Radioimmunoassay ItDGC · Traditional | 06/22/1982SE |
| K812227 | Gammacoat (125) Insulin RadioimmunoassayCFP · Traditional | 09/24/1981SE |
| K810722 | Gastrin Radioimmunoassay TestCGC · Traditional | 05/27/1981SE |
| K810967 | In-Vitro TBG Radioimmunoassay TestCEE · Traditional | 04/23/1981SE |
Questions and answers
When was Ria Kit, Gammacoat cleared by the FDA?
Ria Kit, Gammacoat (K782109) received a 510(k) decision of Substantially Equivalent on January 26, 1979, 38 days after the submission was received.
What is the product code of K782109?
The FDA product code is CDX – Radioimmunoassay, Total Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1700.