LCQ — Fluorescent Immunoassay Gentamicin Class II
FDA product code LCQ covers "Fluorescent Immunoassay Gentamicin", a Class II medical device regulated under 21 CFR 862.3450. Submissions are reviewed by the Clinical Toxicology panel. At least 19 recent 510(k) clearances have been granted under this product code.
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 |