ACCESS(R) FREE T4 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS FREE T3 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THE BIO-TEK UW-II

FDA 510(k)

FDA Class 2 ·Physical Medicine

MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMER. BIO-SCIENCE LAB CORTISOL REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RAPID TOX CUP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PHADEBACT MONOCLONAL GC TEST, MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

UNITOX BOTOX SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Blue Sky Bio Aligner

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI

FDA 510(k)

FDA Class 2 ·Immunology

CROSSVENT-4 VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

STRAIGHT-LINES I.V. ORGANIZER

FDA 510(k)

FDA Class 2 ·General Hospital

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics

ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEUROTECH BAXOLVE TYPE 294

FDA 510(k)

FDA Class 2 ·Neurology

FEEDBACK EMG SYSTEM, MODEL PE-L00

FDA 510(k)

FDA Class 2 ·Neurology

RAPID DRUG SCREEN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

'RAPIDONE'-METHADONE TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology