Orion Diagnostica, Inc.

FDA 510(k) & PMA Approved Devices — 28 products

Total Devices28

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K942286	DIARLEX ROTA-ADENO	LIQ	1994-12-14	View
510(k)	K914892	SALIVA-STIM	EGD	1992-09-02	View
510(k)	K904655	PYLORISET	LYR	1991-10-21	View
510(k)	K884074	IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G	DAH	1988-10-27	View
510(k)	K884147	IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M	DFT	1988-10-27	View
510(k)	K884075	IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN	DDG	1988-10-19	View
510(k)	K884040	IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A	CZP	1988-10-19	View
510(k)	K864645	ADENOLEX (R) LATEX AGGLUTINATION TEST	GOD	1987-06-04	View
510(k)	K871196	RHEUMA-CHECK ENZYME IMMUNOASSAY TEST	DHR	1987-05-06	View
510(k)	K862475	RESPIRASTICK ENZYME IMMUNOASSAY TEST	GTY	1986-09-16	View
510(k)	K854129	ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS	LIQ	1986-01-21	View
510(k)	K844399	RESPIRALEX LATEX AGGLUTINATION TEST	GTZ	1985-01-08	View
510(k)	K841319	ROTALEX LATEX AGGLUTINATION TEST	LIQ	1984-09-14	View
510(k)	K831124	BIOCULT - GC CULTURE-PADDLES	JTY	1983-05-09	View
510(k)	K821659	RESPIRACULT-STREP DEEP BED CULTURE PAD	JSH	1982-08-05	View
510(k)	K802931	INFLUENZA A & B S-ANTIGEN & CONTROLS	GNX	1981-01-12	View
510(k)	K802930	CYTOMEGALO VIRUS & CONTROLS	GQH	1981-01-09	View
510(k)	K802935	PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR	GQS	1980-12-31	View
510(k)	K802933	MUMPS S & V ANTIGENS & CONTROLS	GRC	1980-12-31	View
510(k)	K802929	ADENO VIRUS & CONTROLS	GOD	1980-12-31	View