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LGS — Fluorescence Polarization Immunoassay, Theophylline Class II

FDA Device Classification

Classification Details

Product Code
LGS
Device Class
Class II
Regulation Number
862.3880
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K070810biokitARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)June 8, 2007
K955567oxis intlINNOFLUOR THEOPHYLLINE ASSAY SYSTEMJanuary 24, 1996
K953016abbott laboratoriesAXSYM THEOPHYLLINE IIAugust 24, 1995
K951169ciba corning diagnosticsCIBA CORINING ACS THEOPHYLLINE IMMUNOASSAYJune 20, 1995
K942991seradynQMS THEOPHYLLINE CSSeptember 9, 1994
K932127abbott laboratoriesTDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL IIAugust 9, 1993
K922991abbott laboratoriesABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINEAugust 27, 1992
K900706innotron of oregonMODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRAApril 12, 1990
K894529colony laboratoriesFPR THEOPHYLLINE KITSeptember 15, 1989
K871484roche diagnostic systemsCOBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORSMay 28, 1987
K870277american monitorMONITORX LASERX THEOPHYLLINE REAGENT SETFebruary 18, 1987
K850629innotron diagnosticsINNOFLUOR THEOPHYLLINEMarch 12, 1985
K843826roche diagnostic systemsCOBAS IMMUNOASSAY FOR THEOPHYLLINE & CALFebruary 1, 1985