REDLINE ANTHRAX ALERT TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody

FDA classification

FDA Class 2 ·Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody

IPOS G.L.P. SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

CARIOLINE(ELECTROCARDIOGRAPH)

FDA 510(k)

FDA Class 2 ·Cardiovascular

EPO-RIA

FDA 510(k)

FDA Class 2 ·Hematology

Access EPO

FDA 510(k)

FDA Class 2 ·Hematology

XENX STONE MANAGEMENT DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Kerecis Reconstruct

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCESS EPO ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1

FDA 510(k)

FDA Class 2 ·Immunology

STIMWEAR GARMENTS, SIGNAL I AND SIGNAL II

FDA 510(k)

FDA Class 2 ·Neurology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius System 100 and GI Genius System 200

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WAKO AUTOKIT APO B

FDA 510(k)

FDA Class 2 ·Immunology

APO-Easy Genotyping kit

FDA 510(k)

FDA Class 2 ·Immunology

APO-TEK LP(A)

FDA 510(k)

FDA Class 2 ·Immunology

APOLIPOPROTEIN CALIBRATOR (APO-CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

K-ASSAY APO AI

FDA 510(k)

FDA Class 2 ·Immunology