IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION

FDA 510(k)

FDA Class 1 ·Microbiology

IMAGEN

FDA 510(k)

FDA Class 1 ·Microbiology

IDEIA(TM) ROTAVIRUS

FDA 510(k)

FDA Class 1 ·Microbiology

IMAGEN RESPIRATORY SCREEN

FDA 510(k)

FDA Class 1 ·Microbiology

IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3

FDA 510(k)

FDA Class 1 ·Microbiology

IMAGEN RESPIRATORY SCREEN

FDA 510(k)

FDA Class 1 ·Microbiology

PROCHECK(TM) BLIND PERFORMANCE SPECIMENS

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

MYCOAKT M KANSASII CULTURE ID KIT

FDA 510(k)

FDA Class 1 ·Microbiology

MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT

FDA 510(k)

FDA Class 1 ·Microbiology

MYCOAKT M. AVIUM CULTURE ID KIT

FDA 510(k)

FDA Class 1 ·Microbiology

OPD-SCAN, MODELS ARK-10000 AND ARK-9000

FDA 510(k)

FDA Class 1 ·Ophthalmic

ATR 3000, ATR 2000, IMPLANT-PRO

FDA 510(k)

FDA Class 1 ·Dental

JEJE TEETHER

FDA 510(k)

FDA Class 1 ·Dental

NICCHECK I

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

OPD-STATION SOFTWARE

FDA 510(k)

FDA Class 1 ·Ophthalmic

LATEX SURGICAL GLOVES (YUETONG ENTERPRISE CO. LTD)

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

ELECSYS CA 15-3 II CALCHECK 5

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

OPERAID DISPOS. IRRIGATING KNIFE

FDA 510(k)

FDA Class 1 ·Ophthalmic

Beta-CrossLaps CalCheck 5

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LAKE OSTOMY CARE SET

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology