DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACA IMMUNOGLOBIN A TEST PACK

FDA 510(k)

FDA Class 2 ·Immunology

ACA THYROXINE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VALPROIC ACID ANALYTICAL TEST PACK

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DU PONT TOBRAMYCIN ASSAY REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

S90 Exp Series Digital Color Doppler Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Ultrasonic Gastrovideoscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HD-550 Video Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Flexible Video Cysto-Urethroscope (C-view)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KARL STORZ ShuntScope

FDA 510(k)

FDA Class 2 ·Neurology

Flex-THOR scope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Telepack X LED

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

FDA classification

FDA Class 2 ·Disodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes

Azo Dye, Calcium

FDA classification

FDA Class 2 ·Azo Dye, Calcium

Antiserum, Gentamicin

FDA classification

FDA Class 2 ·Antiserum, Gentamicin

Tester, Auditory Impedance, Exempt

FDA classification

FDA Class 2 ·Tester, Auditory Impedance, Exempt