LCR — Fluorescent Immunoassay, Tobramycin Class II
FDA Device Classification
Classification Details
- Product Code
- LCR
- 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 |
|---|
| K060998 | seradyn | QMS TOBRAMYCIN | July 21, 2006 |
| K974029 | chiron diagnostics | ACS TOBRAMYCIN | February 12, 1998 |
| K962818 | dade intl | TOBRAMYCIN FLEX REAGENT CARTRIDGE | September 13, 1996 |
| K952568 | beckman instruments | BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT | August 8, 1995 |
| K911940 | pb diagnostic systems | OPUS(R) TOBRAMYCIN | July 1, 1991 |
| K911613 | exmoor plastics | VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 | June 28, 1991 |
| K854873 | mira | INTRAOCULAR PRESSURE REDUCER | February 4, 1986 |
| K850058 | e.i. dupont de nemours and co | DU PONT TOBRAMYCIN ASSAY REAGENTS | January 18, 1985 |
| K840847 | paragon diagnostics | IMMPULSE TOBRAMYCIN ASSAY REAGENTS | April 4, 1984 |
| K832408 | american dade | STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM | August 26, 1983 |
| K822197 | kelleher | NEEDLE HOLDERS | August 16, 1982 |
| K821542 | electro-nucleonics laboratories | VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA | June 3, 1982 |
| K820130 | syva | ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY | February 5, 1982 |
| K813542 | american diagnostic | TOBRAMYCIN FLUORESCENT IMMUNOASSAY | January 12, 1982 |
| K810941 | miles laboratories | AMES TDA TOBRAMYCIN TEST | April 17, 1981 |
| K802668 | abbott laboratories | CYBREX TOBRAMYCIN | November 24, 1980 |
| K801308 | intl. diagnostic technology | FIAX TEST KIT FOR TOBRAMYCIN QUANTITA | June 20, 1980 |