Product code LGS— Clinical Toxicology

FDA has cleared 13 devices under product code LGS between 1985 and 2007, filed by 10 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.

• 20071 clearance
• 19961 clearance
• 19952 clearances
• 19941 clearance
• 19931 clearance
• 19921 clearance
• 19901 clearance
• 19891 clearance
• 19872 clearances
• 19852 clearances

• Abbott Laboratories3 clearances
• Roche Diagnostic Systems, Inc.2 clearances
• Seradyn, Inc.1 clearance
• Oxis Intl., Inc.1 clearance
• Innotron of Oregon, Inc.1 clearance
• Innotron Diagnostics1 clearance
• Colony Laboratories, Inc.1 clearance
• Ciba Corning Diagnostics Corp.1 clearance
• Biokit, S.A.1 clearance
• American Monitor Corp.1 clearance

• K070810 — ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)Biokit, S.A.·2007-06-08
• K955567 — INNOFLUOR THEOPHYLLINE ASSAY SYSTEMOxis Intl., Inc.·1996-01-24
• K953016 — AXSYM THEOPHYLLINE IIAbbott Laboratories·1995-08-24
• K951169 — CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAYCiba Corning Diagnostics Corp.·1995-06-20
• K942991 — QMS THEOPHYLLINE CSSeradyn, Inc.·1994-09-09
• K932127 — TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL IIAbbott Laboratories·1993-08-09
• K922991 — ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINEAbbott Laboratories·1992-08-27
• K900706 — MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRAInnotron of Oregon, Inc.·1990-04-12
• K894529 — FPR THEOPHYLLINE KITColony Laboratories, Inc.·1989-09-15
• K871484 — COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORSRoche Diagnostic Systems, Inc.·1987-05-28
• K870277 — MONITORX LASERX THEOPHYLLINE REAGENT SETAmerican Monitor Corp.·1987-02-18
• K850629 — INNOFLUOR THEOPHYLLINEInnotron Diagnostics·1985-03-12
• K843826 — COBAS IMMUNOASSAY FOR THEOPHYLLINE & CALRoche Diagnostic Systems, Inc.·1985-02-01