GLUCOMANAGER DATA MANAGEMENT SOFTWARE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Efai Pacs Picture Archiving and Communication System Pro

FDA 510(k)

FDA Class 2 ·Radiology

EFAI RTSUITE CT HCAP-Segmentation System

FDA 510(k)

FDA Class 2 ·Radiology

AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Starly pad

FDA 510(k)

FDA Class 2 ·Neurology

EFAI ChestSuite XR Pleural Effusion Assessment System

FDA 510(k)

FDA Class 2 ·Radiology

SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Disposable Endoscope Valve Sets

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMS Neck Massager

FDA 510(k)

FDA Class 2 ·Physical Medicine

E-PASS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anit-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601