MODIFICATION TO N PROTEIN STANDARD SL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OPUS PROCAINAMIDE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BERICHROM ALPHA-2-ANTIPLASMIN

FDA 510(k)

FDA Class 2 ·Hematology

EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MICROSCAN MICROSTREP PLUS PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OPUS T3 CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BERICHROM PROTEIN C KIT

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION SPECIAL PROTEIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

N/T PROTEIN CONTROL SL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PANTRAK E.K.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry