FDA 510(k) Applications for Medical Device Product Code "DJD"
(Enzyme Immunoassay, Primidone)

FDA 510(k) Number Applicant Device Name Decision Date
K813597 ABBOTT LABORATORIES TDX PRIMIDONE 01/22/1982
K820138 BECKMAN INSTRUMENTS, INC. PRIMIDONE REAGENT TEST KIT 01/28/1982
K781957 E.I. DUPONT DE NEMOURS & CO., INC. ANALYTICAL TEST PACK, PRIMIDONE 01/10/1979
K802654 MILES LABORATORIES, INC. AMES TDA PRIMIDONE TEST 11/12/1980
K973582 SCHIAPPARELLI BIOSYSTEMS, INC. ACE PRIMIDONE REAGENT, AED CALIBRATORS 11/12/1997
K910527 SYVA CO. EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE 03/14/1991
K840939 SYVA CO. EMIT QST PRIMIDONE ASSAY 04/24/1984
K832798 SYVA CO. MODIFICA-OF EMIT AED PRIMIDONE ASSAY 10/14/1983


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