LVivo Seamless

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA Pre-Market Approval

FDA Class 2 ·AIA-PACK PA PSA, ST AIA-PACK PA PSA

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

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

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M EIA

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

FDA Pre-Market Approval

FDA Class 2 ·AIA-PACK PA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB (R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

Radialis PET Camera

FDA 510(k)

FDA Class 2 ·Radiology

SMOKE EVACUATION ATTACHEMENT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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