MICROCYCLER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUALITY CONTROL SYSTEM, SPECTRA

FDA 510(k)

FDA Class 2 ·Hematology

OLYMPUS AFP - ALPHA-FETOPROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CONCEIVE ONE-STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211

FDA 510(k)

FDA Class 2 ·Immunology

CLEARBLUE EASY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABBOTT MODIFIED FACT PLUS PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GENERIC PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ONE STEP HCG PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUIK-CHECK HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PREG-Q EARLY PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

E.P.T. CERTAINTY 1-STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UNIVAL CONTROL CELLS

FDA 510(k)

FDA Class 2 ·Hematology

BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HOME CLINIC PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUICKSTICK ONE STEP PREGNANCY TEST(9010)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry