GDS-DC12

FDA 510(k)

FDA Class 2 ·Cardiovascular

GDS-DCS

FDA 510(k)

FDA Class 2 ·Cardiovascular

GDS ENZYMATIC THEOPHYLLINE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GDS ENZYMATIC ACETAMINOPHEN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GDS ENZYMATIC SALICYLATE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090

FDA 510(k)

FDA Class 2 ·Hematology

CONTROL AND LINEARITY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACETASITE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SYMPHONY GRAFT DELIVERY SYSTEM (GDS)

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

GraftGun Universal Graft Delivery System (GDS)

FDA 510(k)

FDA Class 2 ·General Hospital

RNG SERIES ULTRASOUND NEEDLE/CATH. GDS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

GLUCOSITE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEMOSITE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

HEMOSITE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

CHOLESITE TEST SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ULTRA-FRESH DEODORANT

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

GentleCath Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology