510(k) K832163
- Device
- Sopheia Digoxin Eia Kit
- Applicant
- DIAGNOSTIC PRODUCTS CORP.
- 510(k) number
- K832163
- Product code
- DPO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-08-12
- Date received
- 1983-07-05
- Regulation
- 862.3320
- Classification name
- Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DPO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914833 | IMMULITE DIGOXIN | Cirrus Diagnostics, Inc. | 1991-11-22 |
| K905719 | ECLIPSE ICA DIGOXIN | Biotope, Inc. | 1991-01-17 |
| K864449 | DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT | Canadian Bioclinical, Ltd. | 1987-02-02 |
| K833842 | RIA COAT DIGOXIN | Immuno Assay Corp. | 1984-01-17 |
| K830962 | IMMUCHEM COVALENT-COAT RIA KIT | Immuchem Corp. | 1983-05-04 |
| K811932 | COAT-A-COUNT DIGOXIN RIA | Diagnostic Products Corp. | 1981-07-23 |
| K811776 | KALLESTAD QUANTICOAT 125 DIGOXIN | Kallestad Laboratories, Inc. | 1981-07-10 |
| K800205 | RIA PHASE DIGOXIN | Boehringer Mannheim Corp. | 1980-03-19 |
| K791325 | AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM | Micromedic Systems | 1979-08-16 |
| K791355 | VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT | Ventrex Laboratories, Inc. | 1979-08-10 |
| K771638 | IGOXIN SOLID PHASE RIA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-10-07 |
| K770365 | RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO | Travenol Laboratories, S.A. | 1977-02-24 |
| K770069 | DIGOXIN CLASP TM RIA KIT | E. R. Squibb & Sons, Inc. | 1977-01-18 |