Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

CLINICAL ELECTRONIC THERMOMETERS, MODEL(S) MT901, MT518, ECT-1

FDA 510(k)

FDA Class 2 ·General Hospital

UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips

FDA 510(k)

FDA Class 2 ·Hematology

uDR 780i

FDA 510(k)

FDA Class 2 ·Radiology

X-cera Zirconia Blanks

FDA 510(k)

FDA Class 2 ·Dental

Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Iontophoresis Electrodes

FDA 510(k)

FDA Class 2 ·Physical Medicine

CAROTID COIL

FDA 510(k)

FDA Class 2 ·Radiology

Checkme Pro Health Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ultrasonic Doppler (Model YM-2T8)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RADIAL ARTERY COMPRESSION TOURNIQUET

FDA 510(k)

FDA Class 2 ·Cardiovascular

DURADIAGNOST

FDA 510(k)

FDA Class 2 ·Radiology

DORA Disposable A.V. Fistula Needle Sets

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

FDA 510(k)

FDA Class 2 ·Clinical Toxicology