TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

HEARING AID (ALL-IN-THE-EAR)

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

MIRACLE-EAR OR AUDIOTONE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

RUBELLA ANTIBODIES TEST REAGENTS

FDA 510(k)

FDA Class 2 ·Microbiology

TPSA FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D

FDA 510(k)

FDA Class 2 ·Hematology

NU.EAR SD-1 IN THE EAR (ITE) HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

N LP(A) STANDARD SY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYSMEX AUTOMATED COAGULATION ANALYZER CA-500

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POST-AURICULAR HEARING AID MODEL PE 805CD2

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RAPITEX(R) ASL NEW

FDA 510(k)

FDA Class 1 ·Microbiology

N APOLIPOPROTEIN STANDARD SERUM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N PROTEIN STANDARD SY

FDA 510(k)

FDA Class 2 ·Immunology

MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

ENZYGNOST(R) TOXOPLASMOSIS/IGG

FDA 510(k)

FDA Class 2 ·Microbiology