FDA 510(k) Applications for Medical Device Product Code: DIP (Enzyme Immunoassay, Diphenylhydantoin)

FDA 510(k) Applications for Medical Device Product Code "DIP"
(Enzyme Immunoassay, Diphenylhydantoin)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K080696	ABBOTT LABORATORIES	ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01	09/11/2008
K963840	BOEHRINGER MANNHEIM CORP.	CEDIA PHENYTOIN II ASSAY	11/20/1996
K000006	DIAGNOSTIC PRODUCTS CORP.	IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6	02/28/2000
K011393	RANDOX LABORATORIES, LTD.	RANDOX PHENYTOIN	12/04/2001
K030428	ROCHE DIAGNOSTICS CORP.	ROCHE ONLINE TDM PHENYTOIN	04/28/2003
K973414	SCHIAPPARELLI BIOSYSTEMS, INC.	ACE PHENYTOIN REAGENT, AED CALIBRATORS	11/04/1997
K993026	SYVA CO.	ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS	01/27/2000
K011347	SYVA CO.	EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229	05/17/2001
K063145	THERMO ELECTRON OY	PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS	10/17/2007