DADE RPR CARD TEST

FDA 510(k)

FDA Class 2 ·Microbiology

RSR CARD TEST

FDA 510(k)

FDA Class 2 ·Microbiology

VISUWELL REAGIN II

FDA 510(k)

FDA Class 2 ·Microbiology

ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO

FDA 510(k)

FDA Class 2 ·Immunology

ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250

FDA 510(k)

FDA Class 2 ·Immunology

ViVi® Toga Premium

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Codman Electrosurgical Generator, Foot Pedal

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Attachment, Intermittent Mandatory Ventilation (Imv)

FDA classification

FDA Class 2 ·Attachment, Intermittent Mandatory Ventilation (Imv)

CARDIOSMART

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIO SERV

FDA 510(k)

FDA Class 2 ·Cardiovascular

Gas Chromatography, Primidone

FDA classification

FDA Class 2 ·Gas Chromatography, Primidone

Test, Albumin Cobalt Binding

FDA classification

FDA Class 2 ·Test, Albumin Cobalt Binding

Ankle Fusion Cage

FDA classification

FDA Class 2 ·Ankle Fusion Cage

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

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System

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

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System

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

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA

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

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

FDA Pre-Market Approval

FDA Class 2 ·CA 125 ANTIBODY RIA

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA