ReliOn Premier Lancing Device

FDA registration

ARKRAY, INC.·1 product·🇯🇵 Japan

Multi-Lancet Device 2

FDA registration

ARKRAY Industry West Inc.·1 product·🇵🇭 Philippines

Synergy Health AST, SRL

FDA registration

Synergy Health AST, SRL·1 product·🇨🇷 Costa Rica

XPRESS MULTI-SINUS DILATION TOOL

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK

FDA 510(k)

FDA Class 2 ·Immunology

DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DUPONT ACA PLUS PROLACTIN (PROL) METHOD

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DUPONT CRONEX PORTABLE GRID CASSETTE

FDA 510(k)

FDA Class 2 ·Radiology

DUPONT DIMENSION TOTAL PROTEIN METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CREATINE KINASE METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URINARY ALBUMIN TEST PACK

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CRONEX REGULAR CASSETTE

FDA 510(k)

FDA Class 2 ·Radiology

DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Instrument, Ent Manual Surgical

FDA classification

FDA Class 1 ·Instrument, Ent Manual Surgical

Plethysmograph, Impedance

FDA classification

FDA Class 2 ·Plethysmograph, Impedance