EMIT THYROXINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PARAMOUNT THYROXINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIOCIRCUITS IOS T4 TEST CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CEDIA TOTAL T4 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OREIA-Q-TY, ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

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

MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI

FDA 510(k)

FDA Class 2 ·Cardiovascular

MC BIO Supertack Tack 3mm, 4mm and 5mm

FDA 510(k)

FDA Class 2 ·Dental

MatriStem UBM Pericardial Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

Drakon™ and Sequre® Microcatheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

125-IMPLANT SEEDS, MODEL STM1250

FDA 510(k)

FDA Class 2 ·Radiology

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Drakon and Sequre Microcatheters

FDA 510(k)

FDA Class 2 ·Cardiovascular