DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA TOBRAMY-CIN ANALYTICAL TEST PACK

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Vision

FDA 510(k)

FDA Class 2 ·Dental

FilmArray Warrior Control Panel M290

FDA 510(k)

FDA Class 2 ·Microbiology

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPQ TEST SYSTEM FOR HAPTOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

DADE BEHRING COAGULATION ANALYZER (BCT)

FDA 510(k)

FDA Class 2 ·Hematology

EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

PROCHEM INDICATOR TAPE

FDA 510(k)

FDA Class 2 ·General Hospital

VivaChek Ino Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TROPONIN (TROP) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

FDA 510(k)

FDA Class 2 ·Immunology

PARA CHECK (AKA EIGHT CHECK-C)

FDA 510(k)

FDA Class 2 ·Hematology

VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology