ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRYPTOSPORIDIUM ANTIGEN DETECTION

FDA 510(k)

FDA Class 2 ·Microbiology

NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DISPOSABLE STIMULATING ELECTRODE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GUIDE WIRE EXTENSION

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

CARDIUS-1 AND CARDIS-2

FDA 510(k)

FDA Class 2 ·Radiology

SURECORE BIOPSY DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aptiva Celiac Disease IgG Reagent

FDA 510(k)

FDA Class 2 ·Immunology

SYNVITRO FLUSH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VitalRhythm

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARGELITE 58P (DENTAL ALLOY)

FDA 510(k)

FDA Class 2 ·Dental

S9 VPAP ADAPT WITH H5I

FDA 510(k)

FDA Class 2 ·Anesthesiology

MICROVASIVE INSURG HELICAL & MINI-HELICAL BASKETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PISTON SYRINGES

FDA 510(k)

FDA Class 2 ·General Hospital

IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST

FDA 510(k)

FDA Class 2 ·Immunology

BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962

FDA 510(k)

FDA Class 2 ·Hematology