Fluorescent Immunoassay, Theophylline

FDA product code LER · Class II (moderate risk) · 21 CFR 862.3880 · Clinical Toxicology

15510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K942192Theophylline Fpia Reagent Set and CalibratorsLER · Traditional Sigma Diagnostics, Inc.07/13/1994SE
K905521Cedia(R) Theophylline Assay/ModificationLER · Traditional Microgenics Corp.12/26/1990SE
K882570Turbox Theophylline AssayLER · Traditional Unipath , Ltd.11/10/1988SE
K864409Immpulse Coated Tube Theophylline Assay ReagentsLER · Traditional Sclavo, Inc.12/22/1986SE
K863475Theofast(Tm) Test PackageLER · Traditional 3M Company11/05/1986SE
K842585Theophylline Kit Fluorescence Polariza-LER · Traditional Windsor Laboratories, Inc.09/26/1984SE
K840758Immpulse Theophylline Assay ReagentsLER · Traditional Paragon Diagnostics, Inc.04/04/1984SE
K833070TDX TheophyllineLER · Traditional Abbott Laboratories11/14/1983SE
K831514Amwa Tda Theophylline TestLER · Traditional Miles Laboratories, Inc.06/30/1983SE
K823576Cobas Standard for Total ProteinLER · Traditional Hoffmann-La Roche, Inc.01/07/1983SE
K820397Amerifluor Theophylline Fluorescent ImmLER · Traditional American Diagnostic Corp.03/02/1982SE
K813240Emit-Aad Theophylline AssayLER · Traditional Syva Co.12/03/1981SE
K812518Ames Tda Theophylline TestLER · Traditional Miles Laboratories, Inc.09/23/1981SE
K811856Fluoromatic Theophylline FiaLER · Traditional Bio-Rad07/10/1981SE
K810943Ames Tda Theophylline TestLER · Traditional Miles Laboratories, Inc.04/17/1981SE

Recalls

RecallProductFirmInitiated
Z-0958-2007 IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system is…A decrease in mP values (calibration curve Net Polarization value) has been observed with this reagent lot… Abbott Diagnostic International, Ltd.04/11/2007Terminated