LCR — Fluorescent Immunoassay, Tobramycin Class II
FDA product code LCR covers "Fluorescent Immunoassay, Tobramycin", a Class II medical device regulated under 21 CFR 862.3900. Submissions are reviewed by the Clinical Toxicology panel. At least 17 recent 510(k) clearances have been granted under this product code.
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 |