Ventre/Sep Digoxin Radioimmunoassay Kit
FDA 510(k) K791355 · Ventrex Laboratories, Inc.
510(k) numberK791355
Submission
- Device name
- Ventre/Sep Digoxin Radioimmunoassay Kit
- Applicant
- Ventrex Laboratories, Inc.
Mchenry, IL, US - Received
- July 21, 1979
- Decision date
- August 10, 1979
- 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 |
| 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 |
More from Micromedic Systems
| 510(k) | Device | Decision |
|---|---|---|
| K914554 | Specific Ige Eia-Turbo AssayDHB · Traditional | 03/13/1992SE |
| K913833 | Ventrex Allergen DiscDHB · Traditional | 02/21/1992SE |
| K913434 | Ventrex Coated Tube Intact PTHCEW · Traditional | 10/25/1991SE |
| K905612 | Ventrex Coated Tube Ige RadioimmunoassayDGC · Traditional | 02/21/1991SE |
| K905636 | Ventrex Coated Tube Ige Enzyme ImmunoassayDHB · Traditional | 02/07/1991SE |
| K905247 | SHBG Irma KitCDZ · Traditional | 01/17/1991SE |
| K904330 | Turbo-Rast Specific Ige AssayDHB · Traditional | 12/07/1990SE |
| K903000 | Turbo-Rast Specific Ige AssayJHR · Traditional | 07/31/1990SE |
| K897083 | Ventresign Strep a TestGTZ · Traditional | 01/22/1990SE |
| K895649 | Coated Tube High Sensitivity TSH 200 Uiu/Ml Stan.JIT · Traditional | 01/18/1990SE |
Questions and answers
When was Ventre/Sep Digoxin Radioimmunoassay Kit cleared by the FDA?
Ventre/Sep Digoxin Radioimmunoassay Kit (K791355) received a 510(k) decision of Substantially Equivalent on August 10, 1979, 20 days after the submission was received.
What is the product code of K791355?
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.