ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

M2376A DEVICELINK SYSTEM, MODEL M2376A

FDA 510(k)

FDA Class 2 ·Cardiovascular

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

FDA 510(k)

FDA Class 2 ·Immunology

LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605

FDA 510(k)

FDA Class 2 ·Immunology

HP M2376A DEVICE LINK SYSTEM, MODEL M2376A

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO M2376A DEVICELINK SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A

FDA 510(k)

FDA Class 2 ·Cardiovascular

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT

FDA 510(k)

FDA Class 2 ·Microbiology

BARBITURATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL

FDA 510(k)

FDA Class 2 ·Microbiology