RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

FDA 510(k)

FDA Class 2 ·Hematology

Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

FDA classification

FDA Class 2 ·Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

ADVANCED DIAGNOSTIC VIEWER (ADV)

FDA 510(k)

FDA Class 2 ·Radiology

ADVANCE MODEL UDS-ADV

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AD/V A.5

FDA 510(k)

FDA Class 2 ·Radiology

ABBOTT AXSYM TROPONIN-I ADV

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABBOTT AXSYM TROPONIN-I ADV

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Panther Fusion AdV/hMPV/RV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Panther Fusion AdV/hMPV/RV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MANDOMETER III

FDA 510(k)

FDA Class 2 ·Neurology

CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ODI-Tech

FDA 510(k)

FDA Class 2 ·Cardiovascular

GlucoSure Link Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BGM014 Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PleuraFlow System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery