Diagoxin Squibb Radioimmunoassay Kit
FDA 510(k) K810966 · E. R. Squibb & Sons, Inc.
510(k) numberK810966
Submission
- Device name
- Diagoxin Squibb Radioimmunoassay Kit
- Applicant
- E. R. Squibb & Sons, Inc.
New York, NY, US - Received
- April 8, 1981
- Decision date
- April 21, 1981
- 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 |
| K802841 | Digoxin Radioimmunoassay KitDNL · Traditional | American Diagnostic Corp. | 12/18/1980SE |
| K781834 | Test Set, 125 I-DigoxinDNL · Traditional | Wien Laboratories, Inc. | 01/03/1979SE |
| 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 |
|---|---|---|
| K821494 | Ria Stat 16JJJ · Traditional | 06/03/1982SE |
| K820616 | Angiotensis I-Squibb RadioimmunoassayCIB · Traditional | 03/26/1982SE |
| K820341 | Cortisol-Squibb Radioimmunoassay KitCGR · Traditional | 03/04/1982SE |
| K820340 | T3 Uptake-Squibb Diagnostic KitKHQ · Traditional | 03/04/1982SE |
| K811240 | Sur-Fit Loop Ostomy O.R. SetEXB · Traditional | 06/16/1981SE |
| K811239 | Sur-Fit Disposable Convex InsertEXB · Traditional | 06/09/1981SE |
| K811160 | Sur-Fit Irrigation SleeveEXD · Traditional | 06/02/1981SE |
| K811163 | Sur-Fit Disposable Fange CapEXB · Traditional | 05/21/1981SE |
| K810211 | T3 Ria KitCDP · Traditional | 02/10/1981SE |
| K803100 | Stomahesive Paste Protective Skin BarrEZR · Traditional | 01/08/1981SE |
Questions and answers
When was Diagoxin Squibb Radioimmunoassay Kit cleared by the FDA?
Diagoxin Squibb Radioimmunoassay Kit (K810966) received a 510(k) decision of Substantially Equivalent on April 21, 1981, 13 days after the submission was received.
What is the product code of K810966?
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.