FDA 510(k) Applications for Medical Device Product Code "LER"
(Fluorescent Immunoassay, Theophylline)

FDA 510(k) Number Applicant Device Name Decision Date
K863475 3M COMPANY THEOFAST(TM) TEST PACKAGE 11/05/1986
K833070 ABBOTT LABORATORIES TDX THEOPHYLLINE 11/14/1983
K820397 AMERICAN DIAGNOSTIC CORP. AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM 03/02/1982
K811856 BIO-RAD FLUOROMATIC THEOPHYLLINE FIA 07/10/1981
K823576 HOFFMANN-LA ROCHE, INC. COBAS STANDARD FOR TOTAL PROTEIN 01/07/1983
K905521 MICROGENICS CORP. CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION 12/26/1990
K810943 MILES LABORATORIES, INC. AMES TDA THEOPHYLLINE TEST 04/17/1981
K812518 MILES LABORATORIES, INC. AMES TDA THEOPHYLLINE TEST 09/23/1981
K831514 MILES LABORATORIES, INC. AMWA TDA THEOPHYLLINE TEST 06/30/1983
K840758 PARAGON DIAGNOSTICS, INC. IMMPULSE THEOPHYLLINE ASSAY REAGENTS 04/04/1984
K864409 SCLAVO, INC. IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS 12/22/1986
K942192 SIGMA DIAGNOSTICS, INC. THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS 07/13/1994
K813240 SYVA CO. EMIT-AAD THEOPHYLLINE ASSAY 12/03/1981
K882570 UNIPATH LTD. TURBOX THEOPHYLLINE ASSAY 11/10/1988
K842585 WINDSOR LABORATORIES, INC. THEOPHYLLINE KIT FLUORESCENCE POLARIZA- 09/26/1984


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