Product code LFW— Clinical Toxicology

FDA has cleared 10 devices under product code LFW between 1984 and 1997, filed by 8 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.

• 19971 clearance
• 19942 clearances
• 19911 clearance
• 19901 clearance
• 19891 clearance
• 19871 clearance
• 19852 clearances
• 19841 clearance

• Roche Diagnostic Systems, Inc.2 clearances
• Innotron of Oregon, Inc.2 clearances
• Windsor Laboratories, Inc.1 clearance
• Sigma Diagnostics, Inc.1 clearance
• Microgenics Corp.1 clearance
• Innotron Diagnostics1 clearance
• Colony Laboratories, Inc.1 clearance
• Abbott Laboratories1 clearance

• K964670 — ROCHE COBAS-FP REAGENTS FOR TOBRAMYCINRoche Diagnostic Systems, Inc.·1997-02-04
• K944371 — TOBRAMYCIN FPIA REAGENT SET AND CALIBRATORSigma Diagnostics, Inc.·1994-11-10
• K941614 — AXSYM TOBRAMYCINAbbott Laboratories·1994-08-18
• K912143 — CEDIA(R) TOBRAMYCIN ASSAYMicrogenics Corp.·1991-07-26
• K900707 — MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATORInnotron of Oregon, Inc.·1990-04-20
• K894531 — FPR TOBRAMYCIN KITColony Laboratories, Inc.·1989-09-01
• K872562 — INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SETInnotron of Oregon, Inc.·1987-08-17
• K854392 — TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMUWindsor Laboratories, Inc.·1985-12-05
• K843828 — COBAS REAGENTS FOR TOBRAMYCIN & CALIBRARoche Diagnostic Systems, Inc.·1985-02-01
• K841866 — INNOFLOUR TOBRAMYCINInnotron Diagnostics·1984-05-31