Sopheia Digoxin Eia Kit
FDA 510(k) K832163 · Diagnostic Products Corp.
510(k) numberK832163
Submission
- Device name
- Sopheia Digoxin Eia Kit
- Applicant
- Diagnostic Products Corp.
Mchenry, IL, US - Received
- July 5, 1983
- Decision date
- August 12, 1983
- 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 |
| K833842 | Ria Coat DigoxinDPO · Traditional | Immuno Assay Corp. | 01/17/1984SE |
| 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 |
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Questions and answers
When was Sopheia Digoxin Eia Kit cleared by the FDA?
Sopheia Digoxin Eia Kit (K832163) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 38 days after the submission was received.
What is the product code of K832163?
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.