American Dade

FDA 510(k) & PMA Approved Devices — 149 products

Total Devices149

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K873051	STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY	CGJ	1987-10-20	View
510(k)	K873171	STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY	JHX	1987-09-29	View
510(k)	K873052	STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY	CEP	1987-09-14	View
510(k)	K872789	PARAMAX URINE/CSF CALIBRATOR	JIX	1987-09-02	View
510(k)	K872195	DATA-FI DIMERTEST LATEX ASSAY	DAP	1987-08-06	View
510(k)	K872196	AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III	JJS	1987-07-31	View
510(k)	K871972	STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY	DGE	1987-07-21	View
510(k)	K871977	DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR	JJY	1987-07-09	View
510(k)	K872050	PARAMAX CHOLESTEROL REAGENT	LBS	1987-07-07	View
510(k)	K872360	DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET	GHH	1987-07-06	View
510(k)	K870158	STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.	CEC	1987-03-19	View
510(k)	K870406	SMI DIGITRON	JQW	1987-02-25	View
510(k)	K870353	IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)	GGP	1987-02-10	View
510(k)	K870354	IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)	GGP	1987-02-10	View
510(k)	K864274	THROMBOPLASTIN.R	GJS	1986-11-13	View
510(k)	K864273	THROMBOPLASTIN.C	GJS	1986-11-13	View
510(k)	K864272	THROMBOPLASTIN.FS	GJS	1986-11-13	View
510(k)	K863887	SMI MULTIPETTOR(TM)	JQW	1986-11-05	View
510(k)	K863594	ACTIN FSL ACTIVATED PTT REAGENT	GGW	1986-10-17	View
510(k)	K863489	PARAMAX ELECTROLYTE CALIBRATOR	JIX	1986-09-29	View