AUDIOTONE MODEL A-98

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

AUDIOTONE MODEL A-54

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

EMIT II PLUS ECSTASY ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VSA 3000 VIBRATORYN SENSORY ANALYZER

FDA 510(k)

FDA Class 1 ·Neurology

GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

MIRACLE EAR MIRAGE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

CLIBRATION PLASMAS

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROTEIN C REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

MULTITROL IMMUNOLOGY CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

N LATEX B2-MICROGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

MULTI-CHANNEL COMPRESSION BTE (SD)

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

FIBRINOGEN CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Hematology

MICROSCAN MICROSTREP PLUS PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500

FDA 510(k)

FDA Class 2 ·Hematology

DENTAL DRILL

FDA 510(k)

FDA Class 1 ·Dental