Test, Ria, Serum Digoxin
FDA 510(k) K760077 · Smithkline Diagnostics, Inc.
510(k) numberK760077
Submission
- Device name
- Test, Ria, Serum Digoxin
- Applicant
- Smithkline Diagnostics, Inc.
Mchenry, IL, US - Received
- June 18, 1976
- Decision date
- July 16, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DND – Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3300
- Specialty
- Clinical Toxicology
More from Smithkline Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961062 | Flexsure ObtKHE · Traditional | 11/06/1996SE |
| K960183 | Flexsure Hp,Controls for Flexsurehp,Flexpack Hp(Abbott Diagnostics)Andcontrols for…LYR · Traditional | 06/07/1996SE |
| K934863 | Flexsure HPLYR · Traditional | 05/18/1994SE |
| K880499 | Hemoccult Sensitive TestKHE · Traditional | 05/23/1988SE |
| K875131 | (SKD) Cholesterol Test KitCHH · Traditional | 03/01/1988SE |
| K862849 | Hemoccult Wipe TestKHE · Traditional | 12/09/1986SE |
| K854723 | SKD Electrochemical System (Ecs)CEM · Traditional | 03/05/1986SE |
| K852841 | Rapid Direct Strep a Latex Agglutination TestGTZ · Traditional | 07/24/1985SE |
| K821884 | Gastroccult TMKHE · Traditional | 10/08/1982SE |
| K821674 | Spinchem Acid Phosphatase ReagentCKB · Traditional | 06/22/1982SE |
Questions and answers
When was Test, Ria, Serum Digoxin cleared by the FDA?
Test, Ria, Serum Digoxin (K760077) received a 510(k) decision of Substantially Equivalent on July 16, 1976, 28 days after the submission was received.
What is the product code of K760077?
The FDA product code is DND – Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3300.