Panels › Clinical Toxicology › Product code DJB · Class 2
Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
Regulation 862.3450
0510(k)s in 12 months (19 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DJB
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Products Corp. | 3 | 0 |
| Miles Laboratories, Inc. | 3 | 0 |
| Bio-Rad | 2 | 0 |
| New England Nuclear | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| Alpha Gamma Laboratory | 1 | 0 |
| Antibodies, Inc. | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 0 |
| Kallestad Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 1983 | K832792 | AMES TDA SISOMICIN TEST-CONTROL SERUM Miles Laboratories, Inc. | DJB |
| May 25, 1983 | K831210 | GENTAMICIN TEST PACK-ACA E.I. Dupont DE Nemours & Co., Inc. | DJB |
| Dec 15, 1982 | K821669 | AMES TDA GENTAMICIN TEST Miles Laboratories, Inc. | DJB |
| Sep 8, 1981 | K812394 | MRI GENTAMICIN RIA KIT Microanalytic Research, Inc. | DJB |
| Jul 10, 1981 | K811844 | COAT-A-COUNT GENTAMICIN RIA KIT Diagnostic Products Corp. | DJB |
| Apr 24, 1980 | K800537 | GAMMA STICK GENTAMICIN RIA KIT Alpha Gamma Laboratory | DJB |
| Oct 17, 1979 | K791770 | QUANTIMUNE GENTAMICIN RIA GENTAMICIN Bio-Rad | DJB |
| Oct 12, 1979 | K791547 | FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY Bio-Rad | DJB |
| Aug 28, 1979 | K782049 | BIOASSAY SYSTEM, MS-2 SERUM Abbott Laboratories | DJB |
| Jun 15, 1979 | K790584 | AMES TDA/GENTGMICIN Miles Laboratories, Inc. | DJB |
| May 15, 1979 | K790829 | EMIT GENTAMICIN ASSAY Syva Co. | DJB |
| Feb 15, 1979 | K782126 | RIA KIT, SISOMICIN Diagnostic Products Corp. | DJB |
| Nov 15, 1978 | K781674 | MACRO-VUE TEST, GENTAMICIN Bd Becton Dickinson Vacutainer Systems Preanalytic | DJB |
| Apr 28, 1978 | K780516 | GENTAMICIN RIA KIT Antibodies, Inc. | DJB |
| Apr 28, 1978 | K772116 | AMINOGLYCOSIDE TEST SYSTEM Nichols Institute Diagnostics | DJB |
| Mar 17, 1978 | K780323 | QUANTITOPE 125-I GENTAMICIN RIA KIT Kallestad Laboratories, Inc. | DJB |
| Jan 5, 1978 | K772425 | RIANEN GENTAMICIN RIA KIT New England Nuclear | DJB |
| Mar 1, 1977 | K761157 | AMINOGLYCOSIDE (125I) RIA KIT Diagnostic Products Corp. | DJB |
| Jul 20, 1976 | K760068 | KIT, RIA, GENTAMICIN SULF. New England Nuclear | DJB |
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