Panels › Clinical Toxicology › Product code LGS · Class 2
Fluorescence Polarization Immunoassay, Theophylline
Regulation 862.3880
0510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LGS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 8, 2007 | K070810 | ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) Biokit, S.A., ES | LGS |
| Jan 24, 1996 | K955567 | INNOFLUOR THEOPHYLLINE ASSAY SYSTEM Oxis Intl., Inc. | LGS |
| Aug 24, 1995 | K953016 | AXSYM THEOPHYLLINE II Abbott Laboratories | LGS |
| Jun 20, 1995 | K951169 | CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY Ciba Corning Diagnostics Corp. | LGS |
| Sep 9, 1994 | K942991 | QMS THEOPHYLLINE CS Seradyn, Inc. | LGS |
| Aug 9, 1993 | K932127 | TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II Abbott Laboratories | LGS |
| Aug 27, 1992 | K922991 | ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE Abbott Laboratories | LGS |
| Apr 12, 1990 | K900706 | MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA Innotron of Oregon, Inc. | LGS |
| Sep 15, 1989 | K894529 | FPR THEOPHYLLINE KIT Colony Laboratories, Inc. | LGS |
| May 28, 1987 | K871484 | COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS Roche Diagnostic Systems, Inc. | LGS |
| Feb 18, 1987 | K870277 | MONITORX LASERX THEOPHYLLINE REAGENT SET American Monitor Corp. | LGS |
| Mar 12, 1985 | K850629 | INNOFLUOR THEOPHYLLINE Innotron Diagnostics | LGS |
| Feb 1, 1985 | K843826 | COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL Roche Diagnostic Systems, Inc. | LGS |
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