DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BINAX L.S. TSH IRMA TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHOLESTEROL CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPECIFIC IGE EIA-TURBO ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

VFS1 Bipolar Electrosurgical Generator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WOUNDCHEK Bacterial Status

FDA 510(k)

FDA Class 2 ·Microbiology

BINAXNOW PBP2A TEST, MODEL 890-000

FDA 510(k)

FDA Class 2 ·Microbiology

OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PEAK FLOW MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Prosthesis, Penile

FDA classification

FDA Class 2 ·Prosthesis, Penile

MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

M-60 GOLD BASE DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER

FDA 510(k)

FDA Class 2 ·General Hospital

TYCHE PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

IPL hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CALCIUM REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81

FDA 510(k)

FDA Class 2 ·General Hospital