JOX · Class II · 21 CFR 864.5680

FDA Product Code JOX: Analyzer, Heparin, Automated

Leading manufacturers include Medtronic, Inc., Medtronic Vascular and Streck Laboratories, Inc..

15
Total
15
Cleared
68d
Avg days
1980
Since

FDA 510(k) Cleared Analyzer, Heparin, Automated Devices (Product Code JOX)

15 devices
1–15 of 15
Cleared Jun 08, 2011
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
K111339
Medtronic, Inc.
Hematology · 27d
Cleared Nov 04, 2010
HEPARIN DOSE RESPONSE CARTRIDGE
K102953
Medtronic, Inc.
Hematology · 31d
Cleared Oct 13, 2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
K101271
Medtronic, Inc.
Hematology · 160d
Cleared Dec 03, 2004
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
K043080
Medtronic Vascular
Hematology · 25d
Cleared Oct 01, 2004
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
K042070
Medtronic Vascular
Hematology · 60d
Cleared Jan 26, 1982
HEPAQUANT
K813011
Streck Laboratories, Inc.
Pathology · 91d

About Product Code JOX - Regulatory Context