DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DOCUMENT CHEM III CALIBRATION VERIFICATION TEST

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

FACEPLATE ASSEMBLY

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

VISIONLINK INTERFILE CONVERSION SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

SPECIFIC IGE EIA-TURBO ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BINAX LEGIONELLA URINARY ANTIGEN EIA

FDA 510(k)

FDA Class 2 ·Microbiology

VENTRESCREEN, HCG URINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICRO TARGETING DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICROTABLE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICROTARGETING XL STAR DRIVE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

FETALTROL

FDA 510(k)

FDA Class 2 ·Hematology

VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

GAS, CALIBRATION, SPECIFIED CONCENTRATION

FDA 510(k)

FDA Class 1 ·Anesthesiology

BinaxNOW G6PD Test

FDA 510(k)

FDA Class 2 ·Hematology