TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LapBox Tissue Containment Removal System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARK Voriconazole II Assay Test System

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK CARE DIABETES MANAGMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CRK CONDYLAR RESURFACING TOTAL KNEE

FDA 510(k)

FDA Class 2 ·Orthopedic

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)

FDA 510(k)

FDA Class 2 ·Physical Medicine

TEETH IN AN HOUR - ARK IMPLANT CONCEPT

FDA 510(k)

FDA Class 2 ·Dental

RUBELLA IGG ANTIBODY ELISA TEST SYS

FDA 510(k)

FDA Class 2 ·Microbiology

ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT

FDA 510(k)

FDA Class 2 ·Microbiology

KOAGULAB 40-A AUTOMATED COAGULATION SYS

FDA 510(k)

FDA Class 2 ·Hematology

ORTHO CLASSICAL PATHWAY COMPL. TEST

FDA 510(k)

FDA Class 2 ·Immunology

ORTHO* RUBELLA-G ANTIBODY ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

LYSONIX LIPOPLASTY ACCESS PORT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

LYSONIX ASPIRATION PUMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ORTHO B-HCG SLIDE TEST FOR PREGNANCY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ORTHO* SERUM ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ORTHO VARICELLA-ZOSTER VIRUS IDENT.

FDA 510(k)

FDA Class 2 ·Microbiology

ORTHO ABNORMAL COAGULATION LEVEL I/II

FDA 510(k)

FDA Class 2 ·Hematology

ORTHO SPECTRUM III & ORTHO-MUNE OK

FDA 510(k)

FDA Class 2 ·Hematology