Kallestad Quanticoat 125 Digoxin
FDA 510(k) K811776 · Kallestad Laboratories, Inc.
510(k) numberK811776
Submission
- Device name
- Kallestad Quanticoat 125 Digoxin
- Applicant
- Kallestad Laboratories, Inc.
Mchenry, IL, US - Received
- June 23, 1981
- Decision date
- July 10, 1981
- 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 |
| 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 |
|---|---|---|
| K863681 | Pathfinder(Tm) Direct Antigen Detection SystemLJP · Traditional | 12/03/1986SE |
| K862917 | Pathfinder Rotavirus ChemiluminescentLIQ · Traditional | 10/22/1986SE |
| K863682 | Pathfinder(Tm) Specimen Collection KitJSM · Traditional | 10/10/1986SE |
| K862743 | Pathfinder(Tm) Respiratory Syncytial VirusGQG · Traditional | 09/29/1986SE |
| K862313 | Kallestad Sm/Rnp Test ReagentLKJ · Traditional | 08/06/1986SE |
| K862710 | Kallestad Ssa/Ssb Ena Test ReagentsLLL · Traditional | 07/29/1986SE |
| K855014 | Quantimetric Plus Calibrator/Control Set aJIX · Traditional | 03/14/1986SE |
| K855010 | Quantimetric Plus Igm Reagent KitDFT · Traditional | 02/28/1986SE |
| K855013 | Quantimetric Plus Support PackDEH · Traditional | 02/26/1986SE |
| K855012 | Quantimetric Plus C4 Reagent KitDBI · Traditional | 02/26/1986SE |
Questions and answers
When was Kallestad Quanticoat 125 Digoxin cleared by the FDA?
Kallestad Quanticoat 125 Digoxin (K811776) received a 510(k) decision of Substantially Equivalent on July 10, 1981, 17 days after the submission was received.
What is the product code of K811776?
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.