System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA

MICRO HAEMATOCRIT CENTRIFUGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

uOmnispace

FDA 510(k)

FDA Class 2 ·Radiology

uWS-MR

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

Zeus Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Shanghai Sanyou CARMEN Cervical Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

KEYSTONE PEEK Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

Adena-Zina Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Adena-Zina System

FDA 510(k)

FDA Class 2 ·Orthopedic

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

AIA-PACK CTNI 2ND-GEN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

FDA Pre-Market Approval

FDA Class 2 ·CA 125 ANTIBODY RIA