Ria Coat Digoxin
FDA 510(k) K833842 · Immuno Assay Corp.
510(k) numberK833842
Submission
- Device name
- Ria Coat Digoxin
- Applicant
- Immuno Assay Corp.
Mchenry, IL, US - Received
- November 3, 1983
- Decision date
- January 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPO – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DPO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914833 | Immulite DigoxinDPO · Traditional | Cirrus Diagnostics, Inc. | 11/22/1991SE |
| K905719 | Eclipse Ica DigoxinDPO · Traditional | Biotope, Inc. | 01/17/1991SE |
| K864449 | Digoxin/Ria Kit Coated Tube Radioimmunoassay KitDPO · Traditional | Canadian Bioclinical, Ltd. | 02/02/1987SE |
| K832163 | Sopheia Digoxin Eia KitDPO · Traditional | Diagnostic Products Corp. | 08/12/1983SE |
| K830962 | Immuchem Covalent-Coat Ria KitDPO · Traditional | Immuchem Corp. | 05/04/1983SE |
| K811932 | Coat-A-Count Digoxin RiaDPO · Traditional | Diagnostic Products Corp. | 07/23/1981SE |
| K811776 | Kallestad Quanticoat 125 DigoxinDPO · Traditional | Kallestad Laboratories, Inc. | 07/10/1981SE |
| K800205 | Ria Phase DigoxinDPO · Traditional | Boehringer Mannheim Corp. | 03/19/1980SE |
| K791325 | Autopak 12 Digoxin Test Delivery SystemDPO · Traditional | Micromedic Systems | 08/16/1979SE |
| K791355 | Ventre/Sep Digoxin Radioimmunoassay KitDPO · Traditional | Ventrex Laboratories, Inc. | 08/10/1979SE |
More from Ventrex Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833745 | Riacoat T-4CDX · Traditional | 01/04/1984SE |
| K820089 | TSH (Ria) KitJLW · Traditional | 01/28/1982SE |
| K820074 | Cortisol (Ria) KitCGR · Traditional | 01/28/1982SE |
| K811954 | Combo-Fer Iron DiagnosticJQG · Traditional | 07/27/1981SE |
| K811725 | TBG Diagnostic KitCEF · Traditional | 07/10/1981SE |
| K811213 | T3 (Ria) KitCDP · Traditional | 05/29/1981SE |
| K811212 | Digoxin (Ria) KitDNL · Traditional | 05/21/1981SE |
| K810857 | T3 Uptake KitKHQ · Traditional | 04/08/1981SE |
| K810811 | T4 Ria KitCDX · Traditional | 04/07/1981SE |
Questions and answers
When was Ria Coat Digoxin cleared by the FDA?
Ria Coat Digoxin (K833842) received a 510(k) decision of Substantially Equivalent on January 17, 1984, 75 days after the submission was received.
What is the product code of K833842?
The FDA product code is DPO – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3320.