LVivo Software Application

FDA 510(k)

FDA Class 2 ·Radiology

LVivo IQS

FDA 510(k)

FDA Class 2 ·Radiology

LVivo Seamless

FDA 510(k)

FDA Class 2 ·Radiology

LVivo Seamless

FDA 510(k)

FDA Class 2 ·Radiology

IPL Hair Removal Device (BE965A, BE965B, BE965C)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device (BE932C, BE932D, BE932E)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AIA-PACK TROPONIN I ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK IGE II ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ST AIA-PACK BNP Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK CA 19-9

FDA 510(k)

FDA Class 2 ·Immunology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M (R) EIA

Beagank 4T Plus

FDA 510(k)

FDA Class 2 ·Neurology

NERBRIDGE

FDA 510(k)

FDA Class 2 ·Neurology

ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ST AIA-PACK CA 19-9

FDA 510(k)

FDA Class 2 ·Immunology

ST AIA-PACK AFP ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ST AIA-PACK INTACT PTH ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK TSH 3RD-GEN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ST AIA-PACK CEA ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ST AIA-PACK hsE2 Calibrator Set

FDA 510(k)

FDA Class 2 ·Clinical Chemistry