IQM Integral Quality Monitor (also IQM)

FDA 510(k)

FDA Class 2 ·Radiology

IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

GAMBRO DQM 200

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INTEGRATED DIGITAL MEDICAL RECORD (IDMR)

FDA 510(k)

FDA Class 2 ·Radiology

Neuronaute Plus

FDA 510(k)

FDA Class 2 ·Neurology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS

IDI-MRSA

FDA 510(k)

FDA Class 2 ·Microbiology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M EIA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM HAVAB-M 2.0

KULAVAC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RCT700

FDA 510(k)

FDA Class 2 ·Radiology

VIVIX-S 1717N

FDA 510(k)

FDA Class 2 ·Radiology

QXLink

FDA 510(k)

FDA Class 2 ·Radiology

VIVIX-S 1012N

FDA 510(k)

FDA Class 2 ·Radiology

S-Patch Ex Wearable ECG Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

AIP SYSTEM-METHOD FOR IGM

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOGLOBULIN M REAGENT SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology