Product code LCQ— Clinical Toxicology
'TDXFLX ANALYZER
- Classification name
- Fluorescent Immunoassay Gentamicin
- Device class
- Class 2
- Regulation
- 21 CFR 862.3450
- Advisory panel
- Clinical Toxicology
- Total cleared
- 19
- First cleared
- Most recent
Market context for product code LCQ
FDA has cleared devices under product code LCQ between 1979 and 1997, filed by 17 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1997
- 1996
- 1995
- 1994
- 1991
- 1990
- 1989
- 1985
- 1984
- 1982
- 1981
- 1980
- 1979
Top applicants under product code LCQ
Recent clearances under product code LCQ
- K972609 — VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
- K955569 — INNOFLUOR GENTAMICIN ASSAY SYSTEM
- K945523 — COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
- K943550 — GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
- K905721 — OPUS GENTAMICIN
- K904226 — 'TDXFLX ANALYZER
- K894523 — FPR GENTAMICIN KIT
- K852158 — BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA
- K852013 — GENTAMICIN KIT(FPIA)
- K843827 — COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
- K841865 — INNOFLOUR GENTAMICIN
- K841162 — IMMPULSE GENTAMICIN ASSAY REAGENTS
- K820285 — SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY
- K813539 — GENTAMICIN FLUORESCENT IMMUNOASSAY
- K810942 — AMES TDA GENTAMICIN TEST
- K801867 — DISPOSABLE MEDICATION NEBULIZER
- K801084 — CYBREX GENTAMICIN
- K800032 — FIAX TEST KIT FOR GENTAMICIN QUAN.
- K782025 — GENTAMICIN FLUROIMMUNASSAY KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.