International Technidyne Corp.

FDA 510(k) & PMA Approved Devices — 47 products

Total Devices47

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K120977	DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC	GGN	2013-07-03	View
510(k)	K050016	HEMOCHRON SIGNATURE ELITE	JPA	2005-02-10	View
510(k)	K030818	HEMOCHRON RESPONSE/SYSTEM	JPA	2003-04-02	View
510(k)	K023561	ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM	GKR	2003-01-31	View
510(k)	K020798	HEMOCHRON JR. SIGNATURE +	JPA	2002-03-28	View
510(k)	K010599	PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE	GJS	2001-07-02	View
510(k)	K010193	HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS	KFF	2001-06-06	View
510(k)	K983475	HEMOCHRON RESPONSE	KQG	1999-05-03	View
510(k)	K990449	HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE	JPA	1999-04-13	View
510(k)	K972866	HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT	GJS	1998-09-30	View
510(k)	K974799	HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE	JPA	1998-07-07	View
510(k)	K972831	HEMOCHRON CITRATE APTT	GFO	1997-11-20	View
510(k)	K961835	PROTIME MICROCOAGULATION SYSTEM	GJS	1997-03-12	View
510(k)	K960749	HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT	JBP	1996-08-12	View
510(k)	K951072	PROTIME MICROCOAGULATION SYSTEM	GKP	1995-10-27	View
510(k)	K945078	HEMOCHRON HNPT/FACTOR VI PT+	GJS	1995-04-28	View
510(k)	K944691	ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II	GGN	1995-03-15	View
510(k)	K940957	HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM	JPA	1994-10-18	View
510(k)	K941007	CATALOG NO. J-ACT+ & QC-ACT+	JBP	1994-06-30	View
510(k)	K941159	DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G	JKA	1994-05-19	View