Roche Digital Pathology Dx

FDA 510(k)

FDA Class 2 ·Pathology

Aperio AT2 DX System

FDA 510(k)

FDA Class 2 ·Pathology

AISight Dx

FDA 510(k)

FDA Class 2 ·Pathology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·SAHARA CLINICAL BONE SONOMETER

Wheelchair, Stair Climbing

FDA classification

FDA Class 2 ·Wheelchair, Stair Climbing

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST

FDA 510(k)

FDA Class 2 ·Hematology

VYSIS D7S486/CEP 7 FISH PROBE KIT

FDA 510(k)

FDA Class 2 ·Hematology

MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

FDA 510(k)

FDA Class 2 ·Medical Genetics

IKAROS

FDA 510(k)

FDA Class 2 ·Hematology

BANDVIEW SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

ULTIMAT L4 X L4, LIEBEL-FLARSHEIM

FDA 510(k)

FDA Class 2 ·Radiology

DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING

FDA 510(k)

FDA Class 2 ·Hematology

VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)

FDA 510(k)

FDA Class 2 ·Hematology

SCANSCOPE XT SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

ELECTRA 800 AUTOMATIC COAGULATION TIMER

FDA 510(k)

FDA Class 2 ·Hematology

VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER

FDA 510(k)

FDA Class 2 ·Hematology

OPUS RUBELLA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)

FDA 510(k)

FDA Class 2 ·Hematology