WAKO LDH CII TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SELISA ANTI-N DNA ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers

FDA 510(k)

FDA Class 2 ·General Hospital

AUTOZYME SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

3DNET SUITE

FDA 510(k)

FDA Class 2 ·Radiology

CANDIDA DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA IMMUNODIFFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS

FDA 510(k)

FDA Class 2 ·Microbiology

DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ON THE SPOT CANDIDASURE

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDATE(R) SUPER

FDA 510(k)

FDA Class 2 ·Microbiology

EI-CANDIDA ENZYME IMMUNOASSAY EI1001

FDA 510(k)

FDA Class 2 ·Microbiology

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROLINE SCREEN FOR METHAMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Pentax Medical Video Duodenoscope ED32-i10

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XTJF TYPE Q160VF1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu Duodeno System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology