HELENA HEMOGLOBIN F CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

HBF DILUENT

FDA 510(k)

FDA Class 2 ·Hematology

SICKLE-CELL F TEST

FDA 510(k)

FDA Class 2 ·Hematology

HELENA HBF QUIPLATE CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

Assay, Fetal Hemoglobin

FDA classification

FDA Class 2 ·Assay, Fetal Hemoglobin

MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I

FDA 510(k)

FDA Class 2 ·Physical Medicine

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·FLEX-CARE(R) RINSING, DISINFECTING, AND STORAGE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-SOAK(TM) CONDITIONING SOLUTION WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON MULTI-PURPOSE SOLUTION ID 81573

K6-I DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

KAI SPOT MODEL KMS 200

FDA 510(k)

FDA Class 2 ·Anesthesiology

KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100

FDA 510(k)

FDA Class 2 ·Anesthesiology

K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C

FDA 510(k)

FDA Class 2 ·Immunology

ADVANTAGE

FDA 510(k)

FDA Class 2 ·General Hospital

DIGORA

FDA 510(k)

FDA Class 2 ·Radiology

SUPERNOVA C5 MRI SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CRANEX BASEX D OR CRANEX EXCEL D

FDA 510(k)

FDA Class 2 ·Dental

IND ONE STEP OCCULT BLOOD (FOB) TEST

FDA 510(k)

FDA Class 2 ·Hematology