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Company · US

Hemotec, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1990. Name variants (Inc, Corp, punctuation) are merged.

15510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
JOX	Analyzer, Heparin, Automated	5
JPA	System, Multipurpose For In Vitro Coagulation Studies	5
JBP	Activated Whole Blood Clotting Time	2
GGN	Plasma, Coagulation Control	1
KFF	Assay, Heparin	1
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jul 3, 1990	K902081	CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL Hemotec, Inc.	JBP
Sep 5, 1989	K894466	HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS Hemotec, Inc.	JPA
Sep 5, 1989	K894359	CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS Hemotec, Inc.	JPA
Sep 5, 1989	K894317	HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. Hemotec, Inc.	JOX
Jan 10, 1989	K884590	HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES Hemotec, Inc.	KFF
Mar 9, 1988	K875089	HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN Hemotec, Inc.	JPA
Feb 19, 1988	K880302	CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER Hemotec, Inc.	GGN
Dec 4, 1985	K854377	HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS Hemotec, Inc.	JOX
Dec 4, 1985	K854376	HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS Hemotec, Inc.	JPA
Oct 4, 1985	K853789	ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR Hemotec, Inc.	JPA
Dec 12, 1984	K843459	HEMOTEC ACT I SYSTEM Hemotec, Inc.	JBP
May 25, 1984	K841021	HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM Hemotec, Inc.	JOX
Jun 8, 1983	K830665	HEPCOL SYSTEM B-10 & B-10-P Hemotec, Inc.	JOX
Apr 9, 1982	K820410	HEMOTEC HEPCON/SYSTEM FOUR & FOUR P Hemotec, Inc.	LOX
Mar 19, 1980	K800161	HEPCON/SYSTEM RC-10 Hemotec, Inc.	JOX

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

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