T-4 RIASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOTAL BILIRUBIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE

FDA 510(k)

FDA Class 2 ·Ophthalmic

AST/SGOT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MYALLERGYTEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DONG BANG ACUPUNCTURE NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

C-76 GOLD BASE DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

POLYBONE GRANULE & BLOCK

FDA 510(k)

FDA Class 2 ·Orthopedic

TOTAL PROTEIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

T-3 UPTAKE/RIASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Light Based Device For Dry Age-Related Macular Degeneration

FDA classification

FDA Class 2 ·Light Based Device For Dry Age-Related Macular Degeneration

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX PSA

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

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

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·DTU-ONE ULTRASOUND SCANNER

Implantable Transprostatic Tissue Retractor System

FDA classification

FDA Class 2 ·Implantable Transprostatic Tissue Retractor System

Computerized Cognitive Assessment Aid

FDA classification

FDA Class 2 ·Computerized Cognitive Assessment Aid