ClearanceBrief
Panels › Hematology › Product code JOX · Class 2

Analyzer, Heparin, Automated

Regulation 864.5680

0510(k)s in 12 months (15 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
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Top companies in JOX

Company510(k)sRecalls
Hemotec, Inc.50
Medtronic, Inc.31
Medtronic Vascular20
Cardiovascular Diagnostics, Inc.10
Diagnostica Stago, Inc.01
Hemotech, Inc.10
Medtronic Hemotec, Inc.10
Medtronic Perfusion Systems10
Streck Laboratories, Inc.10
Decided510(k)Device and applicantCode
Jun 8, 2011K111339HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
Medtronic, Inc.
JOX
Nov 4, 2010K102953HEPARIN DOSE RESPONSE CARTRIDGE
Medtronic, Inc.
JOX
Oct 13, 2010K101271HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
Medtronic, Inc.
JOX
May 24, 2005K051040HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
Medtronic Perfusion Systems
JOX
Dec 3, 2004K043080HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
Medtronic Vascular
JOX
Oct 1, 2004K042070HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
Medtronic Vascular
JOX
Jan 14, 2000K993519RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
Cardiovascular Diagnostics, Inc.
JOX
Jul 21, 1992K922031HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL
Medtronic Hemotec, Inc.
JOX
Jul 17, 1991K911240HEPCON HMS WITH BODY SURFACE AREA CALCULATION
Hemotech, Inc.
JOX
Sep 5, 1989K894317HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
Hemotec, Inc.
JOX
Dec 4, 1985K854377HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS
Hemotec, Inc.
JOX
May 25, 1984K841021HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM
Hemotec, Inc.
JOX
Jun 8, 1983K830665HEPCOL SYSTEM B-10 & B-10-P
Hemotec, Inc.
JOX
Jan 26, 1982K813011HEPAQUANT
Streck Laboratories, Inc.
JOX
Mar 19, 1980K800161HEPCON/SYSTEM RC-10
Hemotec, Inc.
JOX

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