GULLSORB IGG INACTIVATION REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

GE MR MAX SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ORTHO ABNORMAL PROTEIN C CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

CAPTIA(R) SYPHILIS-G

FDA 510(k)

FDA Class 2 ·Microbiology

HELENA THROMBOPLASTIN REAGENT, MODIFICATION

FDA 510(k)

FDA Class 2 ·Hematology

CORONARY GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER

FDA 510(k)

FDA Class 2 ·General Hospital

OPTICA 120 ND:YAG SURGICAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)

FDA 510(k)

FDA Class 2 ·General Hospital

ROTO REST; TRAUMA AND INTENSIVE CARE BED

FDA 510(k)

FDA Class 2 ·Physical Medicine

PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357

FDA 510(k)

FDA Class 2 ·Hematology

ALLERG*ENS ENZYME IMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BINAX IRMA TOTAL BETA-HCG TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

ORTHO CORRECTION REAGENTS

FDA 510(k)

FDA Class 2 ·Hematology

PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

THYROXINE MICROASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THERMOCOUPLE ADAPTER

FDA 510(k)

FDA Class 2 ·General Hospital

CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER

FDA 510(k)

FDA Class 2 ·Hematology