Hematology
FDA medical specialty panel: Hematology. Product code prefix: HE.
8 companies · 29 devicesSonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (K223635)
Class Class II K223635 JBP
Xpert® FII & FV (K223046)
Class Class II K223046 NPR
vWF Ag (K220728)
Class Class II K220728 GGP
ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) (K242127)
Class Class II K242127 GKP
INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (K240315)
Class Class II K240315 QLU
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K243858)
Class Class II K243858 JPA
HemosIL CL HIT-IgG(PF4-H) (K243374)
Class Class II K243374 LCO
Cito CBC System (K240402)
Class Class II K240402 GKZ
Alinity h-series System (K243283)
Class Class II K243283 GKZ
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K251024)
Class Class II K251024 JPA
SQA-iOw Sperm Quality Analyzer (K243114)
Class Class II K243114 POV
LensHooke X12 PRO Semen Analysis System (K242388)
Class Class II K242388 POV
ConcizuTrace ELISA (DEN240035)
Class Class II DEN240035 SES
LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer (K242830)
Class Class II K242830 POV
Automated Blood Coagulation Analyzer CN-Series (CN-6000) (K250965)
Class Class II K250965 JPA
Sysmex XR-Series (XR-10) Automated Hematology Analyzer (K250943)
Class Class II K250943 GKZ
Sysmex XR-Series (XR-20) Automated Hematology Analyzer (K251371)
Class Class II K251371 GKZ
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (K243144)
Class Class II K243144 JOY
microINR System (K251564)
Class Class II K251564 GJS
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (K251968)
Class Class II K251968 KQJ
Blood Volume Analyzer (200) (K251087)
Class Class II K251087 JWO
CRYOcheck Chromogenic Factor VIII (K251440)
Class Class II K251440 GGP
Quantra QStat Cartridge (K251404)
Class Class II K251404 QFR
iQ200 Series (K252580)
Class Class II K252580 LKM
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