QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTASE PHE/GAL SCREENING ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTASE PHENYLALANINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SAS SHIGELLA BOYDII TYPE 4 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SHIGELLA BOYDII TYPE 5 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SHIGELLA DYSENTERIAE TYPE 3 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SHIGELLA BOYDII GROUP C2 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

ReWalk P6.0

FDA 510(k)

FDA Class 2 ·Physical Medicine

INNOVASA STAT*SEAL TOPICAL HEMOSTAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ReDS System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·AFP CONTROL PACK

CONSULTIVA REPORT STATION, MODEL RS-1

FDA 510(k)

FDA Class 2 ·Radiology

SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PHILIPS HERCEPTEST DIGITAL SCORE

FDA 510(k)

FDA Class 2 ·Hematology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

SI-Restore Sacroiliac Joint Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

IP-SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NOGA

FDA 510(k)

FDA Class 2 ·Cardiovascular