LGS

13 FDA 510(k) clearances · Product code

59 daysmedian time to decision

98 days90th percentile

13clearances measured

FDA profile

Official device name: Fluorescence Polarization Immunoassay, Theophylline
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.3880
Medical specialty: Clinical Toxicology
Flags: Third-party review eligible
Adverse events (MAUDE): 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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Record	Firm	Date
ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) (K070810)	Biokit, S.A.	2007-06-08
INNOFLUOR THEOPHYLLINE ASSAY SYSTEM (K955567)	Oxis Intl., Inc.	1996-01-24
AXSYM THEOPHYLLINE II (K953016)	Abbott Laboratories	1995-08-24
CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY (K951169)	Ciba Corning Diagnostics Corp.	1995-06-20
QMS THEOPHYLLINE CS (K942991)	Seradyn, Inc.	1994-09-09
TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II (K932127)	Abbott Laboratories	1993-08-09
ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE (K922991)	Abbott Laboratories	1992-08-27
MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA (K900706)	Innotron of Oregon, Inc.	1990-04-12
FPR THEOPHYLLINE KIT (K894529)	Colony Laboratories, Inc.	1989-09-15
COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS (K871484)	Roche Diagnostic Systems, Inc.	1987-05-28
MONITORX LASERX THEOPHYLLINE REAGENT SET (K870277)	American Monitor Corp.	1987-02-18
INNOFLUOR THEOPHYLLINE (K850629)	Innotron Diagnostics	1985-03-12
COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL (K843826)	Roche Diagnostic Systems, Inc.	1985-02-01

Track LGS automatically

Every clearance here is in the API, with alerts when new ones post.