Panels › Clinical Toxicology › Product code DNL · Class 2
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
Regulation 862.3320
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DNL
| Company | 510(k)s | Recalls |
|---|---|---|
| American Diagnostic Corp. | 1 | 0 |
| Clinical Assays, Inc. | 1 | 0 |
| E. R. Squibb & Sons, Inc. | 1 | 0 |
| Immuno Assay Corp. | 1 | 0 |
| M Nobird, Inc. | 1 | 0 |
| New England Nuclear | 1 | 0 |
| Nuclear Diagnostics, Inc. | 1 | 0 |
| Wien Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 9, 1985 | K852343 | DIG RADIOIMMUNOASSAY TEST SYSTEM M Nobird, Inc. | DNL |
| Jun 25, 1985 | K852291 | TIPSEP DIGOXIN RIA Nuclear Diagnostics, Inc. | DNL |
| May 21, 1981 | K811212 | DIGOXIN (RIA) KIT Immuno Assay Corp. | DNL |
| Apr 21, 1981 | K810966 | DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT E. R. Squibb & Sons, Inc. | DNL |
| Dec 18, 1980 | K802841 | DIGOXIN RADIOIMMUNOASSAY KIT American Diagnostic Corp. | DNL |
| Jan 3, 1979 | K781834 | TEST SET, 125 I-DIGOXIN Wien Laboratories, Inc. | DNL |
| Sep 14, 1978 | K781495 | RIANEN ASSAY SYSTEM, 125I KIT New England Nuclear | DNL |
| Nov 22, 1977 | K772110 | IN VITRO DIGOXIN RIA TEST Clinical Assays, Inc. | DNL |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.