Panels › Clinical Toxicology › Product code DPO · Class 2
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Regulation 862.3320
0510(k)s in 12 months (14 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DPO
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Products Corp. | 2 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Biotope, Inc. | 1 | 0 |
| Boehringer Mannheim Corp. | 1 | 0 |
| Canadian Bioclinical, Ltd. | 1 | 0 |
| Cirrus Diagnostics, Inc. | 1 | 0 |
| E. R. Squibb & Sons, Inc. | 1 | 0 |
| Immuchem Corp. | 1 | 0 |
| Immuno Assay Corp. | 1 | 0 |
| Kallestad Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 22, 1991 | K914833 | IMMULITE DIGOXIN Cirrus Diagnostics, Inc. | DPO |
| Jan 17, 1991 | K905719 | ECLIPSE ICA DIGOXIN Biotope, Inc. | DPO |
| Feb 2, 1987 | K864449 | DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT Canadian Bioclinical, Ltd., CA | DPO |
| Jan 17, 1984 | K833842 | RIA COAT DIGOXIN Immuno Assay Corp. | DPO |
| Aug 12, 1983 | K832163 | SOPHEIA DIGOXIN EIA KIT Diagnostic Products Corp. | DPO |
| May 4, 1983 | K830962 | IMMUCHEM COVALENT-COAT RIA KIT Immuchem Corp. | DPO |
| Jul 23, 1981 | K811932 | COAT-A-COUNT DIGOXIN RIA Diagnostic Products Corp. | DPO |
| Jul 10, 1981 | K811776 | KALLESTAD QUANTICOAT 125 DIGOXIN Kallestad Laboratories, Inc. | DPO |
| Mar 19, 1980 | K800205 | RIA PHASE DIGOXIN Boehringer Mannheim Corp. | DPO |
| Aug 16, 1979 | K791325 | AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM Micromedic Systems | DPO |
| Aug 10, 1979 | K791355 | VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT Ventrex Laboratories, Inc. | DPO |
| Oct 7, 1977 | K771638 | IGOXIN SOLID PHASE RIA Bd Becton Dickinson Vacutainer Systems Preanalytic | DPO |
| Feb 24, 1977 | K770365 | RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO Travenol Laboratories, S.A. | DPO |
| Jan 18, 1977 | K770069 | DIGOXIN CLASP TM RIA KIT E. R. Squibb & Sons, Inc. | DPO |
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