XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)

FDA 510(k)

FDA Class 1 ·Microbiology

AXIS %CDT TURBIDIMETRIC IMMUNOASSAY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

TENCEL X-RAY DETECTABLE SPONGES/LAP PADS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR

FDA 510(k)

FDA Class 1 ·General Hospital

SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR

FDA 510(k)

FDA Class 1 ·General Hospital

SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR

FDA 510(k)

FDA Class 1 ·General Hospital

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR

FDA 510(k)

FDA Class 1 ·General Hospital

BIO-RAD %CDT TIA

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

GRI LASERGRAPH(TM) ECG PAPER

FDA 510(k)

FDA Class 1 ·Cardiovascular

AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PATIENT EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

POWDERED VINYL EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

POWDER FREE VINYL EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

POWDERED VINYL EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

TOP GLOVE VINYL EXAMINATION GLOVE

FDA 510(k)

FDA Class 1 ·General Hospital

NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

NASOPORE EAR, MODELS ND04, ND05

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

Device, Paste-On For Incontinence, Non-Sterile

FDA classification

FDA Class 1 ·Device, Paste-On For Incontinence, Non-Sterile