Smithkline Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 42 products

Total Devices42

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K961062	FLEXSURE OBT	KHE	1996-11-06	View
510(k)	K960183	FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)	LYR	1996-06-07	View
510(k)	K934863	FLEXSURE HP	LYR	1994-05-18	View
510(k)	K880499	HEMOCCULT SENSITIVE TEST	KHE	1988-05-23	View
510(k)	K875131	(SKD) CHOLESTEROL TEST KIT	CHH	1988-03-01	View
510(k)	K862849	HEMOCCULT WIPE TEST	KHE	1986-12-09	View
510(k)	K854723	SKD ELECTROCHEMICAL SYSTEM (ECS)	CEM	1986-03-05	View
510(k)	K852841	RAPID DIRECT STREP A LATEX AGGLUTINATION TEST	GTZ	1985-07-24	View
510(k)	K821884	GASTROCCULT TM	KHE	1982-10-08	View
510(k)	K821674	SPINCHEM ACID PHOSPHATASE REAGENT	CKB	1982-06-22	View
510(k)	K821184	SPIN CHEM REAGENTS & STANDARDS	JIY	1982-05-24	View
510(k)	K821183	TARGET ISOCHECK CONTROL SERUM	JJT	1982-05-14	View
510(k)	K812646	SKI 5000	DXK	1981-11-16	View
510(k)	K812471	SPIN-CHEM TRIGLYCERIDES REAGENT	CDT	1981-09-14	View
510(k)	K812472	SPIN-CHEM LD-L REAGENT	CFJ	1981-09-14	View
510(k)	K811850	ESKAFLOW TEST FOR TRIGLYCERIDES	CDT	1981-07-23	View
510(k)	K811849	ESKAFLOW TEST FOR GLUCOSE	CFR	1981-07-15	View
510(k)	K810914	5CM SMALL PARTS SCANNER	IYO	1981-05-08	View
510(k)	K803234	ESKACHEM PAP REAGENT	JFH	1981-02-26	View
510(k)	K801060	HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE	IYO	1980-06-04	View