Test Set, 125 I-Digoxin
FDA 510(k) K781834 · Wien Laboratories, Inc.
510(k) numberK781834
Submission
- Device name
- Test Set, 125 I-Digoxin
- Applicant
- Wien Laboratories, Inc.
Mchenry, IL, US - Received
- October 30, 1978
- Decision date
- January 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DNL – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DNL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K852343 | Dig Radioimmunoassay Test SystemDNL · Traditional | M Nobird, Inc. | 07/09/1985SE |
| K852291 | Tipsep Digoxin RiaDNL · Traditional | Nuclear Diagnostics, Inc. | 06/25/1985SE |
| K811212 | Digoxin (Ria) KitDNL · Traditional | Immuno Assay Corp. | 05/21/1981SE |
| K810966 | Diagoxin Squibb Radioimmunoassay KitDNL · Traditional | E. R. Squibb & Sons, Inc. | 04/21/1981SE |
| K802841 | Digoxin Radioimmunoassay KitDNL · Traditional | American Diagnostic Corp. | 12/18/1980SE |
| K781495 | Rianen Assay System, 125I KitDNL · Traditional | New England Nuclear | 09/14/1978SE |
| K772110 | In Vitro Digoxin Ria TestDNL · Traditional | Clinical Assays, Inc. | 11/22/1977SE |
More from Clinical Assays, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K912850 | SHBGCDZ · Traditional | 08/12/1991SE |
| K834246 | Progesterone Test Set 125I 17-OHJLX · Traditional | 02/04/1984SE |
| K832452 | Androstenedione Test Set 125ICIZ · Traditional | 09/12/1983SE |
| K823200 | 125 I-Dehydroepiandrosterone SulfateJKC · Traditional | 11/29/1982SE |
| K821653 | Protriptyline Tri-Cy Test SetLFG · Traditional | 06/14/1982SE |
| K821652 | Doxepin Tri-Cy Test SetLFG · Traditional | 06/14/1982SE |
| K802728 | 125I-TESTOSTERONE Test SetCDZ · Traditional | 12/11/1980SE |
| K792041 | Dhea-Sulfate Test SetJKC · Traditional | 10/30/1979SE |
| K781599 | I-Estriol Test SetCGI · Traditional | 10/17/1978SE |
| K772306 | 125I Digoxin Test SetDPB · Traditional | 12/22/1977SE |
Questions and answers
When was Test Set, 125 I-Digoxin cleared by the FDA?
Test Set, 125 I-Digoxin (K781834) received a 510(k) decision of Substantially Equivalent on January 3, 1979, 65 days after the submission was received.
What is the product code of K781834?
The FDA product code is DNL – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3320.