OSOM CARD II HCG-URINE TEST, MODEL 102

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOTAL THROXINE MICROPLATE EIA(225-300)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

LUMA-CATH STEERABLE EP CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD

FDA 510(k)

FDA Class 2 ·Immunology

JAZZ SOLO Sensor

FDA 510(k)

FDA Class 2 ·Dental

Triton Sponge System

FDA 510(k)

FDA Class 2 ·General Hospital

5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL

FDA 510(k)

FDA Class 2 ·Orthopedic

OMNI PLUS Surgical System

FDA 510(k)

FDA Class 2 ·General Hospital

KSEA EPIDUROSCOPE

FDA 510(k)

FDA Class 2 ·Orthopedic

RETIC-QUINOX

FDA 510(k)

FDA Class 2 ·Hematology

SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SeaSpine Mariner Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology

FDA 510(k)

FDA Class 2 ·Cardiovascular

Acucy Influenza A&B Test with the Acucy System

FDA 510(k)

FDA Class 2 ·Microbiology

IMMILITE TOTAL IGE

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER

FDA 510(k)

FDA Class 2 ·Immunology

QUICK-LOCK

FDA 510(k)

FDA Class 2 ·Anesthesiology

SYSTEMS PLUS

FDA 510(k)

FDA Class 2 ·Ophthalmic