INSTATEMP

FDA 510(k)

FDA Class 2 ·General Hospital

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS

Geon (S2) Nasal Aspirator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BIODAN TYPE COMET ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AFINION ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

FDA 510(k)

FDA Class 2 ·Immunology

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

AFINION HBALC

FDA 510(k)

FDA Class 2 ·Hematology

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200

FDA 510(k)

FDA Class 2 ·Immunology

HOLOTC RIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology