Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK

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

Inqwire Diagnostic Guide Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

3mensio Workstation

FDA 510(k)

FDA Class 2 ·Radiology

MYLABSIX ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CAAS A-Valve

FDA 510(k)

FDA Class 2 ·Radiology

NHancer Rx

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEMISPHERE MULTIPLANE ENDORECTAL PROBE

FDA 510(k)

FDA Class 2 ·Radiology