ROCHE TSH RIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RENAK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AGGLUTEX AMPHETAMINE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COBAS-BLO REAGENTS (LACTATE DEHYDRO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COBAS REAGENT FOR CREATININE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COBAS STANDARDS FOR CALCIUM-IN-ORGANIC

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS

FDA 510(k)

FDA Class 2 ·Neurology

HCG RIA PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS

FDA 510(k)

FDA Class 2 ·Neurology

MONOLISA ANTI-HAV EIA

FDA 510(k)

FDA Class 2 ·Microbiology

MONOLISA ANTI-HAV IGM EIA

FDA 510(k)

FDA Class 2 ·Microbiology

ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA

FDA 510(k)

FDA Class 2 ·Immunology

IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400

FDA 510(k)

FDA Class 2 ·Cardiovascular

Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

FDA classification

FDA Class 2 ·Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

FDA classification

FDA Class 2 ·Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

S57D DIGITAL OPERATING ROOM CAMERA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOPRO 67D OPERATING ROOM CAMERA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S-57 VIDEO IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology