Dac-Cel Digoxin Radioimmunoassay Kit
FDA 510(k) K780475 · Burroughs Wellcome Co.
510(k) numberK780475
Submission
- Device name
- Dac-Cel Digoxin Radioimmunoassay Kit
- Applicant
- Burroughs Wellcome Co.
Mchenry, IL, US - Received
- March 24, 1978
- Decision date
- April 24, 1978
- 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 |
More from E. R. Squibb & Sons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K820069 | Wellcogen Group BGTZ · Traditional | 02/18/1982SE |
| K813508 | Sac-CelKTS · Traditional | 12/29/1981SE |
| K810215 | Dac-Cel HCGJHI · Traditional | 04/17/1981SE |
| K810214 | Dac-Cel DiagnatalJHI · Traditional | 03/06/1981SE |
| K810213 | Dac-Cel TSHJLW · Traditional | 02/10/1981SE |
| K810212 | Dac-Cel T3 UptakeKHQ · Traditional | 02/10/1981SE |
| K791232 | Dac-Cel T3CDP · Traditional | 09/04/1979SE |
| K791231 | Dac-Cel T4CDX · Traditional | 09/04/1979SE |
| K781607 | Strep-TexGTZ · Traditional | 10/17/1978SE |
| K780874 | Thymune-TDDC · Traditional | 06/14/1978SE |
Questions and answers
When was Dac-Cel Digoxin Radioimmunoassay Kit cleared by the FDA?
Dac-Cel Digoxin Radioimmunoassay Kit (K780475) received a 510(k) decision of Substantially Equivalent on April 24, 1978, 31 days after the submission was received.
What is the product code of K780475?
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.