Panels › Clinical Toxicology › Product code KLB · Class 2
Radioimmunoassay, Tobramycin
Regulation 862.3900
0510(k)s in 12 months (23 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in KLB
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Products Corp. | 3 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 3 | 0 |
| Roche Diagnostics Corp. | 1 | 2 |
| Bio-Rad | 2 | 0 |
| Syva Co. | 2 | 0 |
| Alpha Gamma Laboratory | 1 | 0 |
| Antibodies, Inc. | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Biosan Laboratories, Inc. | 1 | 0 |
| Clinical Assays, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 9, 2006 | K060853 | ONLINE TDM TOBRAMYCIN Roche Diagnostics Corp. | KLB |
| Aug 20, 2001 | K012312 | IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) Diagnostic Products Corp. | KLB |
| Jan 22, 2001 | K003341 | EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS Syva Co., Dade Behring, Inc. | KLB |
| Oct 26, 1990 | K904304 | DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD E.I. Dupont DE Nemours & Co., Inc. | KLB |
| Aug 22, 1990 | K903192 | IL TOBRAMYCIN ASSAY Instrumentation Laboratory CO | KLB |
| Aug 21, 1989 | K893913 | TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD Technicon Instruments Corp. | KLB |
| Jul 1, 1988 | K882294 | EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY Syva Co. | KLB |
| Nov 13, 1987 | K874223 | EMIT TOBRAMYCIN ASSAY Syva Co. | KLB |
| Dec 4, 1985 | K854184 | IN-VITRO TEST DETERMINATION OF TOBRAMYCIN Clinical Data, Inc. | KLB |
| Jul 22, 1985 | K852671 | ACA TOBRAMY-CIN ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. | KLB |
| Mar 23, 1984 | K832763 | TOBRAMYCIN REAGENT Biosan Laboratories, Inc. | KLB |
| Oct 27, 1983 | K832985 | TOBRAMYCIN ANALYTICAL TEST PACK-ACA E.I. Dupont DE Nemours & Co., Inc. | KLB |
| Oct 18, 1982 | K822858 | COAT-A-COUNT TOBRAMYCIN RIA KIT Diagnostic Products Corp. | KLB |
| Dec 29, 1981 | K813516 | MRI TOBRAMYCIN RIA KIT Microanalytic Research, Inc. | KLB |
| Sep 9, 1981 | K812415 | KALLESTAD ANTISERA TO TOBRAMYCIN Kallestad Laboratories, Inc. | KLB |
| Mar 17, 1981 | K810597 | MACRO-VUE CARD TEST Bd Becton Dickinson Vacutainer Systems Preanalytic | KLB |
| Jan 28, 1981 | K810011 | GAMMA STICK 125-1 TOBRAMYCIN RIA KIT Alpha Gamma Laboratory | KLB |
| Apr 16, 1980 | K800743 | TOBRAMYCIN RIA KIT Antibodies, Inc. | KLB |
| Oct 17, 1979 | K791596 | FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY Bio-Rad | KLB |
| Sep 4, 1979 | K791502 | QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO Bio-Rad | KLB |
| Aug 16, 1979 | K791435 | AMES TDA/TOBRAMYCIN Miles Laboratories, Inc. | KLB |
| Aug 14, 1978 | K780934 | IN VITRO TOBRAMYCIN RIA KIT Clinical Assays, Inc. | KLB |
| Dec 22, 1976 | K760967 | TOBRAMYCIN RIA KIT Diagnostic Products Corp. | KLB |
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