Cebtria Digoxin Ria
FDA 510(k) K771255 · Union Carbide Corp.
510(k) numberK771255
Submission
- Device name
- Cebtria Digoxin Ria
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- July 12, 1977
- Decision date
- August 25, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DON – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DON
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K902861 | Ciba Corning Acs Digoxin ImmunoassayDON · Traditional | Ciba Corning Diagnostics Corp. | 09/10/1990SE |
| K881679 | Ciba Corning Magic Lite Digoxin ImmunoassayDON · Traditional | Ciba Corning Diagnostics Corp. | 07/08/1988SE |
| K840461 | Magic 125I Digoxin RadioimmunoassayDON · Traditional | Corning Medical & Scientific | 03/23/1984SE |
| K830533 | Phase II Digoxin Radioimmunoassay KitDON · Traditional | Medical & Scientific Designs, Inc. | 04/05/1983SE |
| K822053 | Zetaphase-DigDON · Traditional | Biological & Diagnostic Products | 07/27/1982SE |
| K821000 | Enzymune-Test DigoxinDON · Traditional | Icl Scientific | 04/26/1982SE |
| K810296 | Digoxin Ria AssayDON · Traditional | Ria Diagnostics | 02/19/1981SE |
| K803075 | Digoxin Riabead Diagnostic KitDON · Traditional | Abbott Laboratories | 12/22/1980SE |
| K791549 | Technicon Star SystemDON · Traditional | Technicon Instruments Corp. | 09/27/1979SE |
| K781660 | Ria, DigoxinDON · Traditional | E. R. Squibb & Sons, Inc. | 10/24/1978SE |
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| K810129 | Centrifichem System 500JJE · Traditional | 02/02/1981SE |
| K803216 | Centrifichem Ast/Sgot Optimized ReagentCIT · Traditional | 01/09/1981SE |
| K802741 | Centrifichem Comb. Serum-Based Calib.JIX · Traditional | 12/10/1980SE |
| K802520 | Centrifichem Pipettor Accuracy Calib.JQW · Traditional | 11/12/1980SE |
Questions and answers
When was Cebtria Digoxin Ria cleared by the FDA?
Cebtria Digoxin Ria (K771255) received a 510(k) decision of Substantially Equivalent on August 25, 1977, 44 days after the submission was received.
What is the product code of K771255?
The FDA product code is DON – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3320.