Tria-Peg Ria Diag. Kit
FDA 510(k) K780292 · Nuclear Diagnostics, Inc.
510(k) numberK780292
Submission
- Device name
- Tria-Peg Ria Diag. Kit
- Applicant
- Nuclear Diagnostics, Inc.
Mchenry, IL, US - Received
- February 21, 1978
- Decision date
- March 2, 1978
- 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
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|---|---|---|---|
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| 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 |
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| K923917 | Elipase Human Pancreatic Lipase EnzymeimmunoassayCHI · Traditional | 02/25/1994SE |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN Pancrea Cath Try Rad KitJNO · Traditional | 12/02/1993SE |
| K872177 | Tipsep-Cortisol Ria Diagnostic KitCGR · Traditional | 06/17/1987SE |
| K862312 | Enzlipase, Enzymatic Lipase KitCHI · Traditional | 09/26/1986SE |
| K860472 | Nuclear Laser Alignment System for Cardic StressIWE · Traditional | 07/03/1986SE |
| K861735 | Tipsep-Tbg AssayCEE · Traditional | 06/13/1986SE |
| K852291 | Tipsep Digoxin RiaDNL · Traditional | 06/25/1985SE |
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Questions and answers
When was Tria-Peg Ria Diag. Kit cleared by the FDA?
Tria-Peg Ria Diag. Kit (K780292) received a 510(k) decision of Substantially Equivalent on March 2, 1978, 9 days after the submission was received.
What is the product code of K780292?
The FDA product code is CDP – Radioimmunoassay, Total Triiodothyronine, a Class II (moderate risk) device regulated under 21 CFR 862.1710.