Digoxin Ria (Peg) Kit
FDA 510(k) K781335 · Ortho Diagnostics, Inc.
510(k) numberK781335
Submission
- Device name
- Digoxin Ria (Peg) Kit
- Applicant
- Ortho Diagnostics, Inc.
Mchenry, IL, US - Received
- August 2, 1978
- Decision date
- August 31, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DOG – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DOG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K810477 | Dca Digox-Syn Ria TestDOG · Traditional | Diagnostic Corp. of America | 03/11/1981SE |
| K803045 | Immu-Trace Digoxin (125I) Radioimmun.DOG · Traditional | American Dade | 12/22/1980SE |
| K760709 | Emit Digokin AssayDOG · Traditional | Syva Co. | 10/21/1976SE |
| K760416 | Data-Tope System Digoxin RiaDOG · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 08/23/1976SE |
More from Dade, Baxter Travenol Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802404 | Ortho Bovine Albumin Solution 30% ProteDCF · Traditional | 10/23/1980SE |
| K801507 | Antigen Control CellsGOL · Traditional | 08/20/1980SE |
| K800357 | Bi-Level Assayed Card. Drug Cont., I,IiLAS · Traditional | 04/16/1980SE |
| K800310 | Ortho Antisera ControlKSF · Traditional | 03/05/1980SE |
| K791791 | Ortho Antibody Enhancement SolutionKSG · Traditional | 10/11/1979SE |
| K791301 | Ortho TSH Ria KitJLW · Traditional | 09/24/1979SE |
| K790813 | Multecon Blood Gas ControlJJS · Traditional | 06/28/1979SE |
| K782166 | Slide Test for Pregnancy, Gravindex 90JHJ · Traditional | 04/04/1979SE |
| K782063 | Pregnancy, Sensidex Tube TestJHJ · Traditional | 04/04/1979SE |
| K781638 | Rubindex*Direct SystemGOK · Traditional | 12/20/1978SE |
Questions and answers
When was Digoxin Ria (Peg) Kit cleared by the FDA?
Digoxin Ria (Peg) Kit (K781335) received a 510(k) decision of Substantially Equivalent on August 31, 1978, 29 days after the submission was received.
What is the product code of K781335?
The FDA product code is DOG – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol, a Class II (moderate risk) device regulated under 21 CFR 862.3320.