DIASTAT ANTI-CARDIOLIPIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

MODEL HD-207 BIDIRECTIONAL VELOCITY METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CM & CM DS-7

FDA 510(k)

FDA Class 2 ·Radiology

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KONICA SRX-201 AUTOMATIC X-RA FILM PROCESSOR

FDA 510(k)

FDA Class 2 ·Radiology

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

FDA 510(k)

FDA Class 2 ·Immunology

Bose SoundControl Hearing Aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MySegmenter (v2.0.0)

FDA 510(k)

FDA Class 2 ·Radiology

DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT

FDA 510(k)

FDA Class 2 ·Immunology

DISTAT ANTI-SCL-70 KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-HISTONE KIT

FDA 510(k)

FDA Class 2 ·Immunology

Flume Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

FLUME catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QWIK-CALL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIASTAT ANTI-THYROGLOBULIN KIT

FDA 510(k)

FDA Class 2 ·Immunology