Enzymune-Test Digoxin
FDA 510(k) K821000 · Icl Scientific
510(k) numberK821000
Submission
- Device name
- Enzymune-Test Digoxin
- Applicant
- Icl Scientific
Mchenry, IL, US - Received
- April 8, 1982
- Decision date
- April 26, 1982
- 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 |
| 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 |
| K780475 | Dac-Cel Digoxin Radioimmunoassay KitDON · Traditional | Burroughs Wellcome Co. | 04/24/1978SE |
More from Burroughs Wellcome Co.
| 510(k) | Device | Decision |
|---|---|---|
| K883942 | Hycor Sentry Drugs of Abuse Urine ControlJJY · Traditional | 11/10/1988SE |
| K843565 | Kova Trol I,Ii, III Human Urine-DriedJJW · Traditional | 10/05/1984SE |
| K833761 | Therapeutic Drug ControlDKB · Traditional | 01/13/1984SE |
| K832823 | Enzymune-Test TSHJLW · Traditional | 10/14/1983SE |
| K831383 | Event-Test SlideJHJ · Traditional | 06/22/1983SE |
| K823199 | Enzyme-Test DigoxinKXT · Traditional | 11/29/1982SE |
| K822777 | Therapeutic Drug ControlDIF · Traditional | 10/08/1982SE |
| K822346 | Histimune Enzyme-Ana TestLJM · Traditional | 10/08/1982SE |
| K822465 | Enzymune System IJJE · Traditional | 09/14/1982SE |
| K821374 | Enzymune-Test InsulinCFP · Traditional | 05/28/1982SE |
Questions and answers
When was Enzymune-Test Digoxin cleared by the FDA?
Enzymune-Test Digoxin (K821000) received a 510(k) decision of Substantially Equivalent on April 26, 1982, 18 days after the submission was received.
What is the product code of K821000?
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.