DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION DRUG CALIBRATOR II, MODEL DC49C

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114

FDA 510(k)

FDA Class 2 ·Immunology

DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION TRNF FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

N LATEX FERRITIN

FDA 510(k)

FDA Class 2 ·Immunology

N LATEX CYSTATIN C

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BEHRING COAGULATION TIMER ANALYZER (BCT)

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAR Apollo Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

WIRELESS MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)

FDA 510(k)

FDA Class 2 ·Orthopedic

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·METROSOFT(DELTAFILCONA) HYDROPHILIC CONTACT LENSES

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERIDYNE DYNASPRAY

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·GELFLEX(R) (DIMEFILCON A) CONTACT LENS

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·TESLACON(TM) NMR IMAGING SYSTEM