SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMULITE ACTH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INCSTAR ACTH IRMA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN

FDA 510(k)

FDA Class 2 ·Hematology

VISULIZE FACTOR IX ANTIGEN KIT

FDA 510(k)

FDA Class 2 ·Hematology

CPI RAD VISION

FDA 510(k)

FDA Class 2 ·Radiology

CPI RAD VISION, MODEL VZW2944XX-YY

FDA 510(k)

FDA Class 2 ·Radiology

CPIVISION DIGITAL IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG

FDA 510(k)

FDA Class 2 ·Hematology

VisuCon-F Low Fibrinogen Control Plasma

FDA 510(k)

FDA Class 2 ·Hematology

VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

NTX100 Tonic Motor Activation (NTX100 ToMAc) System

FDA 510(k)

FDA Class 2 ·Neurology

CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001

FDA 510(k)

FDA Class 2 ·Orthopedic

PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800

FDA 510(k)

FDA Class 2 ·Cardiovascular

HFG 350, 650, 1050

FDA 510(k)

FDA Class 2 ·Radiology

VJW2919 PNEUMATIC COMPRESSION UPGRADE

FDA 510(k)

FDA Class 2 ·Radiology

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-LKM-1 ELISA(LGG)

FDA 510(k)

FDA Class 2 ·Immunology