DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N PROTEIN STANDARD PLASMA (HUMAN)

FDA 510(k)

FDA Class 2 ·Immunology

ENZYGNOST ROTAVIRUS AG

FDA 510(k)

FDA Class 1 ·Microbiology

EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION PSA FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

ENZYGNOST(R) TAT REAGENTS

FDA 510(k)

FDA Class 2 ·Hematology

N ANTISERA TO HUMAN CERULOPLASMIN

FDA 510(k)

FDA Class 2 ·Immunology

N/T PROTEIN CONTROL PY

FDA 510(k)

FDA Class 2 ·Hematology

EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ENZYGNOST ANTI-CMV IGM TEST

FDA 510(k)

FDA Class 2 ·Microbiology

POST-SURICULAR HEARING AID PE 600CD

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

N CRP STANDARD SY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION HAIC ASSAY, MODEL DF105

FDA 510(k)

FDA Class 2 ·Hematology

ISOTRAK AMYLASE TEST AMYLASE ISOENZYME

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POST-AURICULAR HEARING AID MODEL PE 600PPCL

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

DIMENSION CTNI FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE

FDA 510(k)

FDA Class 2 ·Microbiology