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

Align

FDA 510(k)

FDA Class 2 ·Orthopedic

MICROLYTE 7

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS

EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM

FDA 510(k)

FDA Class 2 ·Cardiovascular