WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

FDA 510(k)

FDA Class 2 ·Immunology

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX-53 SOFT CONTACT LENSES

NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000

FDA 510(k)

FDA Class 2 ·Neurology

ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000

FDA 510(k)

FDA Class 2 ·Neurology

BURR HOLE COVER, MODEL XX

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGUS PASSIVE PROBE, MODEL NP-1000

FDA 510(k)

FDA Class 2 ·Neurology

ACTIVE ARRAY CATHETER, MODEL CS-2000

FDA 510(k)

FDA Class 2 ·Radiology

NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGUS II MR

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGUS PEEL AWAY INTRODUCER

FDA 510(k)

FDA Class 2 ·Neurology

REMOTE INTRODUCER, MODEL PI-1000

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX

FDA 510(k)

FDA Class 2 ·Neurology

CEDIA DAU BENZODIAZEPINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEDIA DAU BENZODIAZEPINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEDIA DAU PROPOXYPHENE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CEDIA DAU OPIATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology