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Panels › Clinical Toxicology › Product code DJD · Class 2

Enzyme Immunoassay, Primidone

Regulation 862.3680

0510(k)s in 12 months (8 all time)

0recalls in 12 months (0 all time)

0recalls that name a 510(k)

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Top companies in DJD

Company	510(k)s	Recalls
Syva Co.	3	0
Abbott Laboratories	1	0
Beckman Instruments, Inc.	1	0
E.I. Dupont DE Nemours & Co., Inc.	1	0
Miles Laboratories, Inc.	1	0
Schiapparelli Biosystems, Inc.	1	0

Decided	510(k)	Device and applicant	Code
Nov 12, 1997	K973582	ACE PRIMIDONE REAGENT, AED CALIBRATORS Schiapparelli Biosystems, Inc.	DJD
Mar 14, 1991	K910527	EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE Syva Co.	DJD
Apr 24, 1984	K840939	EMIT QST PRIMIDONE ASSAY Syva Co.	DJD
Oct 14, 1983	K832798	MODIFICA-OF EMIT AED PRIMIDONE ASSAY Syva Co.	DJD
Jan 28, 1982	K820138	PRIMIDONE REAGENT TEST KIT Beckman Instruments, Inc.	DJD
Jan 22, 1982	K813597	TDX PRIMIDONE Abbott Laboratories	DJD
Nov 12, 1980	K802654	AMES TDA PRIMIDONE TEST Miles Laboratories, Inc.	DJD
Jan 10, 1979	K781957	ANALYTICAL TEST PACK, PRIMIDONE E.I. Dupont DE Nemours & Co., Inc.	DJD

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