KLB — Radioimmunoassay, Tobramycin Class II
FDA product code KLB covers "Radioimmunoassay, Tobramycin", a Class II medical device regulated under 21 CFR 862.3900. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KLB
- Device Class
- Class II
- Regulation Number
- 862.3900
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K060853 | roche diagnostics | ONLINE TDM TOBRAMYCIN | June 9, 2006 |
| K012312 | diagnostic products | IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) | August 20, 2001 |
| K003341 | syva co., dade behring | EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS | January 22, 2001 |
| K904304 | e.i. dupont de nemours and co | DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD | October 26, 1990 |
| K903192 | instrumentation laboratory | IL TOBRAMYCIN ASSAY | August 22, 1990 |
| K893913 | technicon instruments | TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD | August 21, 1989 |
| K882294 | syva | EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY | July 1, 1988 |
| K874223 | syva | EMIT TOBRAMYCIN ASSAY | November 13, 1987 |
| K854184 | clinical data | IN-VITRO TEST DETERMINATION OF TOBRAMYCIN | December 4, 1985 |
| K852671 | e.i. dupont de nemours and co | ACA TOBRAMY-CIN ANALYTICAL TEST PACK | July 22, 1985 |
| K832763 | biosan laboratories | TOBRAMYCIN REAGENT | March 23, 1984 |
| K832985 | e.i. dupont de nemours and co | TOBRAMYCIN ANALYTICAL TEST PACK-ACA | October 27, 1983 |
| K822858 | diagnostic products | COAT-A-COUNT TOBRAMYCIN RIA KIT | October 18, 1982 |
| K813516 | microanalytic research | MRI TOBRAMYCIN RIA KIT | December 29, 1981 |
| K812415 | kallestad laboratories | KALLESTAD ANTISERA TO TOBRAMYCIN | September 9, 1981 |
| K810597 | bd becton dickinson vacutainer systems preanalytic | MACRO-VUE CARD TEST | March 17, 1981 |
| K810011 | alpha gamma laboratory | GAMMA STICK 125-1 TOBRAMYCIN RIA KIT | January 28, 1981 |
| K800743 | antibodies | TOBRAMYCIN RIA KIT | April 16, 1980 |
| K791596 | bio-rad | FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY | October 17, 1979 |
| K791502 | bio-rad | QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO | September 4, 1979 |