T3 (Ria) Kit
FDA 510(k) K811213 · Immuno Assay Corp.
510(k) numberK811213
Submission
- Device name
- T3 (Ria) Kit
- Applicant
- Immuno Assay Corp.
Mchenry, IL, US - Received
- May 4, 1981
- Decision date
- May 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDP – Radioimmunoassay, Total Triiodothyronine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1710
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001607 | Reprobead T3 Enzyme Immunoassay Reagent Kit (Catalog# 104)CDP · Traditional | Repromedix Corp. | 10/05/2000SE |
| K991692 | Chiron Diagnostics Acs: 180 FT3CDP · Traditional | Chiron Diagnostics Corp. | 06/18/1999SE |
| K991311 | Total T3 Enzyme Immunoassay Test Kit, Model BC-1005CDP · Traditional | Biocheck, Inc. | 06/02/1999SE |
| K991252 | Aia-Pack FT3 AssayCDP · Traditional | Tosoh Medics, Inc. | 05/11/1999SE |
| K981824 | Opticoat T3 Eia KitCDP · Traditional | Biotecx Laboratories, Inc. | 12/22/1998SE |
| K983439 | Abbott Architect Free T3CDP · Traditional | Abbott Laboratories | 11/20/1998SE |
| K983434 | Abbott Architect Total T3CDP · Traditional | Abbott Laboratories | 11/20/1998SE |
| K974027 | Auraflex FT3 150 Test Pack, Auraflex FT3 Calibrator PackCDP · Traditional | Alfa Biotech (Uk) , Ltd. | 02/02/1998SE |
| K974634 | Immulite Free T3CDP · Traditional | Diagnostic Products Corp. | 01/02/1998SE |
| K973966 | Access Total T3 Reagents on the Access Immunoassay AnalyzerCDP · Traditional | Beckman Instruments, Inc. | 10/31/1997SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833842 | Ria Coat DigoxinDPO · Traditional | 01/17/1984SE |
| K833745 | Riacoat T-4CDX · Traditional | 01/04/1984SE |
| K820089 | TSH (Ria) KitJLW · Traditional | 01/28/1982SE |
| K820074 | Cortisol (Ria) KitCGR · Traditional | 01/28/1982SE |
| K811954 | Combo-Fer Iron DiagnosticJQG · Traditional | 07/27/1981SE |
| K811725 | TBG Diagnostic KitCEF · Traditional | 07/10/1981SE |
| K811212 | Digoxin (Ria) KitDNL · Traditional | 05/21/1981SE |
| K810857 | T3 Uptake KitKHQ · Traditional | 04/08/1981SE |
| K810811 | T4 Ria KitCDX · Traditional | 04/07/1981SE |
Questions and answers
When was T3 (Ria) Kit cleared by the FDA?
T3 (Ria) Kit (K811213) received a 510(k) decision of Substantially Equivalent on May 29, 1981, 25 days after the submission was received.
What is the product code of K811213?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.