SIGMA PROCEDURE NO. 333-UV

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ON.SITE ALCOHOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT ST SERUM ETHYL ALCOHOL ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT ST URINE ETHYL ALCOHOL ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RAICHEM(TM) ALCOHOL REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMDS(TM) ALCOHOL TESTPACKS, #67691/95

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ON*SITE ALCOHOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PARAMAX ALCOHOL REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KINETIC 610 ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AXSYM REA ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Nad-Nadh, Specific Reagent For Alcohol Enzyme Method

FDA classification

FDA Class 2 ·Nad-Nadh, Specific Reagent For Alcohol Enzyme Method

DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML

FDA 510(k)

FDA Class 2 ·General Hospital

Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume

FDA 510(k)

FDA Class 2 ·Cardiovascular

ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SENSITIVE EYES(TM) SALINE SOLUTION (2ML) SIZE