LCQ — Fluorescent Immunoassay Gentamicin Class II
FDA Device Classification
Classification Details
- Product Code
- LCQ
- Device Class
- Class II
- Regulation Number
- 862.3450
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K972609 | bio-rad | VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM | August 6, 1997 |
| K955569 | oxis intl | INNOFLUOR GENTAMICIN ASSAY SYSTEM | February 9, 1996 |
| K945523 | roche diagnostic systems | COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS | March 9, 1995 |
| K943550 | sigma diagnostics | GENTAMICIN FPIA REAGENT SET AND CALIBRATORS | November 17, 1994 |
| K905721 | pb diagnostic systems | OPUS GENTAMICIN | February 21, 1991 |
| K904226 | abbott laboratories | 'TDXFLX ANALYZER | October 29, 1990 |
| K894523 | colony laboratories | FPR GENTAMICIN KIT | September 28, 1989 |
| K852158 | bioprobe intl | BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA | June 25, 1985 |
| K852013 | windsor laboratories | GENTAMICIN KIT(FPIA) | June 10, 1985 |
| K843827 | roche diagnostic systems | COBAS REAGENTS FOR GENTAMICIN & CALIBRAT | February 1, 1985 |
| K841865 | innotron diagnostics | INNOFLOUR GENTAMICIN | May 31, 1984 |
| K841162 | paragon diagnostics | IMMPULSE GENTAMICIN ASSAY REAGENTS | May 2, 1984 |
| K820285 | syva | SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY | February 18, 1982 |
| K813539 | american diagnostic | GENTAMICIN FLUORESCENT IMMUNOASSAY | December 31, 1981 |
| K810942 | miles laboratories | AMES TDA GENTAMICIN TEST | April 17, 1981 |
| K801867 | hospitax | DISPOSABLE MEDICATION NEBULIZER | August 20, 1980 |
| K801084 | abbott laboratories | CYBREX GENTAMICIN | May 23, 1980 |
| K800032 | intl. diagnostic technology | FIAX TEST KIT FOR GENTAMICIN QUAN. | January 23, 1980 |
| K782025 | technia diagnostics | GENTAMICIN FLUROIMMUNASSAY KIT | January 26, 1979 |