FDA Product Code JOX: Analyzer, Heparin, Automated
Leading manufacturers include Hemotec, Inc., Medtronic, Inc. and Medtronic Vascular.
15
Total
15
Cleared
68d
Avg days
1980
Since
FDA 510(k) Cleared Analyzer, Heparin, Automated Devices (Product Code JOX)
15 devices
Cleared
Jun 08, 2011
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
Medtronic, Inc.
Hematology
27d
Cleared
Nov 04, 2010
HEPARIN DOSE RESPONSE CARTRIDGE
Medtronic, Inc.
Hematology
31d
Cleared
Oct 13, 2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
Medtronic, Inc.
Hematology
160d
Cleared
May 24, 2005
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
Medtronic Perfusion Systems
Hematology
29d
Cleared
Dec 03, 2004
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
Medtronic Vascular
Hematology
25d
Cleared
Oct 01, 2004
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
Medtronic Vascular
Hematology
60d
Cleared
Jan 14, 2000
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
Cardiovascular Diagnostics, Inc.
Hematology
88d
Cleared
Jul 21, 1992
HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL
Medtronic Hemotec, Inc.
Hematology
81d
Cleared
Jul 17, 1991
HEPCON HMS WITH BODY SURFACE AREA CALCULATION
Hemotech, Inc.
Hematology
118d
Cleared
Sep 05, 1989
HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
Hemotec, Inc.
Hematology
53d
Cleared
Dec 04, 1985
HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS
Hemotec, Inc.
Hematology
35d
Cleared
May 25, 1984
HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM
Hemotec, Inc.
Hematology
74d
Cleared
Jun 08, 1983
HEPCOL SYSTEM B-10 & B-10-P
Hemotec, Inc.
Hematology
97d
Cleared
Jan 26, 1982
HEPAQUANT
Streck Laboratories, Inc.
Pathology
91d
Cleared
Mar 19, 1980
HEPCON/SYSTEM RC-10
Hemotec, Inc.
Hematology
55d