FDA 510(k) Applications for Medical Device Product Code "LFT"
(Fluorescent Immunoassay, Primidone)

FDA 510(k) Number Applicant Device Name Decision Date
K842196 AMERICAN DADE STRATUS PRIMIDONE FLOROMETRIC ENZY 07/11/1984
K822229 AMERICAN DIAGNOSTIC CORP. PRIMIDONE FLUORESCENT IMMUNOASSAY 08/12/1982
K904683 BAXTER HEALTHCARE CORP. STRATUS PRIMIDONE FLUOROMETRIC ENZYME 11/28/1990
K811007 MILES LABORATORIES, INC. AMES TDA TM PRIMIDONE TEST 04/29/1981
K852318 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS 06/25/1985
K950028 SIGMA DIAGNOSTICS, INC. PRIMIDONE FPIA REAGENT SET AND CALIBRATORS 03/21/1995
K823741 SYVA CO. ADVANCE EMIT-AED PRIMEDONE ASSAY 01/07/1983
K895567 TUDOR LABORATORIES, INC. PRIMIDONE (FPIA) KIT 10/20/1989


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