Eclipse Ica Digoxin
FDA 510(k) K905719 · Biotope, Inc.
510(k) numberK905719
Submission
- Device name
- Eclipse Ica Digoxin
- Applicant
- Biotope, Inc.
Redmond, WA, US - Received
- December 21, 1990
- Decision date
- January 17, 1991
- 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 |
| 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 |
| K791355 | Ventre/Sep Digoxin Radioimmunoassay KitDPO · Traditional | Ventrex Laboratories, Inc. | 08/10/1979SE |
More from Ventrex Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K905145 | Eclipse Ica CholesterolCHH · Traditional | 02/26/1991SE |
| K910302 | Eclipse Ica AnalyzerJJQ · Traditional | 02/22/1991SE |
| K910256 | Eclipse Ica TSHJLW · Traditional | 02/22/1991SE |
| K905601 | Eclipse Ica TriglyceridesCDT · Traditional | 01/17/1991SE |
| K905602 | Eclipse Ica BunCDQ · Traditional | 01/16/1991SE |
| K905144 | Eclipse Ica GlucoseCFR · Traditional | 01/04/1991SE |
Questions and answers
When was Eclipse Ica Digoxin cleared by the FDA?
Eclipse Ica Digoxin (K905719) received a 510(k) decision of Substantially Equivalent on January 17, 1991, 27 days after the submission was received.
What is the product code of K905719?
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.