DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

OPUS CMV TEST SYSTEM-MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

DAHLBERG MODEL LT BTE HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DAHLBERG MODEL JMS IN-THE-EAR HEARING INSTRUMENT

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

OPUS TROPONIN I

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

DAHLBERG MODEL LG BTE HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

PHONIC EAR, MODEL PE475R

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PROTEIN S AC

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132

FDA 510(k)

FDA Class 2 ·Clinical Toxicology