SUNCAST D-KF

FDA 510(k)

FDA Class 2 ·Dental

EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W

FDA 510(k)

FDA Class 2 ·Hematology

Medical mask (Model: KKF-1A)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Procedure face mask (Model: KKF-2A)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

SALUMEDICA NERVE CUFF

FDA 510(k)

FDA Class 2 ·Neurology

LIPIDURE REWETTING DROPS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Q-Switched Nd:Yag laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Quo-Test A1c System

FDA 510(k)

FDA Class 2 ·Hematology

Hemo Control (optional Add Pack Hemo Control DM)

FDA 510(k)

FDA Class 2 ·Hematology

DiaSpect Tm, DiaSpect Tm Cuvettes

FDA 510(k)

FDA Class 2 ·Hematology

STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS

FDA 510(k)

FDA Class 2 ·Hematology

MARATHON 6K GENERAL-PURPOSE CENTRIFUGE

FDA 510(k)

FDA Class 2 ·Hematology

GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)

FDA 510(k)

FDA Class 2 ·Hematology

HICHEM ALP/AMP REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE M ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

MICROHEMATOCRIT CENTRIFUGE

FDA 510(k)

FDA Class 2 ·Hematology

MICROSPIN 24

FDA 510(k)

FDA Class 2 ·Hematology

CHEMPRO 1000(TM)

FDA 510(k)

FDA Class 2 ·Hematology

CRIT-SCAN II MONITOR

FDA 510(k)

FDA Class 2 ·Hematology