THE STACHROM HEPARIN ASSAY KIT

FDA 510(k)

FDA Class 2 ·Hematology

KSEA MEDI PACK

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASSERACHROM PF4 KIT

FDA 510(k)

FDA Class 2 ·Hematology

STACLOT LA TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

NEOPLASTINE CI PLUS

FDA 510(k)

FDA Class 2 ·Hematology

UNIDRIVE II PLUS DISPOSABLE TUBING SET

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

UNICALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Hematology

KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

THROMBO-CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Hematology

Freedom Spinal Cord Stimulator System

FDA 510(k)

FDA Class 2 ·Neurology

Radlink GPS Pro Imaging

FDA 510(k)

FDA Class 2 ·Radiology

GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM

STAGO FACTOR XI-DEFICIENT PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

AT-III CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

PROTEIN S CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

STA - VWF CONTROL [N]+[P] KIT

FDA 510(k)

FDA Class 2 ·Hematology

HBPM/LMWH CONTROL KIT

FDA 510(k)

FDA Class 2 ·Hematology

STA D-DI CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Hematology