OPERAND LUBRICATING JELLY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS

FDA 510(k)

FDA Class 2 ·Immunology

Access CEA

FDA 510(k)

FDA Class 2 ·Immunology

CEA DESALTING DOLUMN SEPHADEX R

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE CEA

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS CEA ON THE ELECSYS 1010

FDA 510(k)

FDA Class 2 ·Immunology

CLINETICS PCA COLUMN

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)

FDA 510(k)

FDA Class 2 ·Immunology

Finapres Nova Noninvasive Hemodynamic Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ANGEFLATOR(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIABETES RISK DETECTOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RF-1 CIRCUIT

FDA 510(k)

FDA Class 2 ·Radiology

CTS-3060 AUTOMATED SEMEN ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

FACTOR X DEFICIENT PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

LYME IGM MICROASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO

FDA 510(k)

FDA Class 2 ·Orthopedic