BIOCLONES ELEGANCE LH ELISA KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ESOP HA FEMORAL STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR

FDA 510(k)

FDA Class 2 ·Radiology

R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO KDI QUIK TEST MARIJUANA SCREEN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·VIDAS FREE PSA RT ASSAY

Distal Radius Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

Clarus Viewer

FDA 510(k)

FDA Class 2 ·Radiology

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AXSYM FREE PSA ASSAY

Powersculp laser lipolysis system

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOMECCA CENTRAL CS1

FDA 510(k)

FDA Class 2 ·Cardiovascular

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT AXSYM TOTAL PSA ASSAY

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY

Eurolink Europe Compliance Limited

Authorized representative

🇮🇪 Ireland·35 Manufacturers·252 Devices

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·FPSA FLEX REAGENT CARTRIDGE

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS