GMP CIQ ELISA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

LIFESYNE SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

LAPAROCISION SCOPE CONTROLLER SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VISUWELL REAGIN TEST 960 TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

QUALITROL SYPHSERO CONTROL SET

FDA 510(k)

FDA Class 2 ·Microbiology

BECKMAN R.PR CONTROL SERUM SET

FDA 510(k)

FDA Class 2 ·Microbiology

ADI SYPHILIS RPR LIQUID CONTROLS

FDA 510(k)

FDA Class 2 ·Microbiology

RPR TEST REDITEST

FDA 510(k)

FDA Class 2 ·Microbiology

V-TREND RPRL CARD TEST

FDA 510(k)

FDA Class 2 ·Microbiology

RPR LIQUID CONTROLS

FDA 510(k)

FDA Class 2 ·Microbiology

VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010

FDA 510(k)

FDA Class 2 ·Microbiology

CONTROL SERUMS FOR NONTREPONEMAL TEST

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM/TOTAL PSA

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER PTCA CATHETERS

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY TFC UNITE PRODUCT LINE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY THREADED FUSION CAGE(TFC)