1,733 results · 34ms · Sources: EU EUDAMED, US FDA

OPIATES

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ACCELERATOR APS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TSH-STAT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ETHANOL

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BARBITURATES

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

sagAlign Lumbar Cage System (Various PNs)

FDA 510(k)
FDA Class 2 ·Orthopedic

ESOPHAGEAL MANOMETRY ANALYSIS MODULE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TDX TRANSFERRIN DIAGNOSTIC KIT

FDA 510(k)
FDA Class 2 ·Immunology

OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.

FDA 510(k)
FDA Class 2 ·Immunology

MODIFICATION TO ALKP

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CK

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

A-GENT LIQUID TOTAL BILIRUBIN

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALCYON 300I (WITH ISE MODULE) ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CALCIUM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Alinity i Total ß-hCG Reagent Kit, GLP systems Track

FDA 510(k)
FDA Class 2 ·Clinical Chemistry