WAKO(TM) IGG-HA DIRECT

FDA 510(k)

FDA Class 2 ·Immunology

WAKO(TM) IGM-HA DIRECT

FDA 510(k)

FDA Class 2 ·Immunology

MAGNESIUM STANDARD SOLUTION CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) AUTOKIT LDH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO(TM) AUTOKIT TOTAL PROTEIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URIC ACID STANDARD SOLUTION CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GO-PEN®

FDA 510(k)

FDA Class 2 ·General Hospital

EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.

FDA 510(k)

FDA Class 2 ·Immunology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PREFERRED PLUS 53 SOFT (HYDROPHILIC) ASPHERIC LENS

MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED

FDA 510(k)

FDA Class 2 ·Cardiovascular

Antigen, Elisa, Cryptococcus

FDA classification

FDA Class 2 ·Antigen, Elisa, Cryptococcus

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Custom Anesthesia Tray

FDA classification

FDA Class 2 ·Custom Anesthesia Tray

Dialysis Administration Kit

FDA classification

FDA Class 2 ·Dialysis Administration Kit

Peripheral Catheter Insertion Kit

FDA classification

FDA Class 2 ·Peripheral Catheter Insertion Kit

Chest Drainage Kit

FDA classification

FDA Class 2 ·Chest Drainage Kit