Unipath , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
73
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K061769E.P.T. CERTAINTY 1-STEP PREGNANCY TESTJuly 3, 2006
K060128CLEARBLUE EASY DIGITAL PREGNANCY TESTMay 25, 2006
K051638INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBCDecember 6, 2005
K050930E.P.T. CERTAINTY PREGNANCY TESTMay 12, 2005
K042280FACT PLUS ONE-STEP PREGNANCY TEST KITSeptember 10, 2004
K041404CLEARBLUE EASY EASY READ PREGNANCY TESTJune 8, 2004
K040329MODIFICATION TO E.P.T. PREGNANCY TESTMarch 8, 2004
K040341CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TESTMarch 8, 2004
K033658E.P.T. PREGNANCY TESTJanuary 16, 2004
K032939EPT CERTAINTY PREGNANCY TESTOctober 20, 2003
K030659CLEARBLUE EASY DIGITAL PREGNANCY TESTMay 2, 2003
K023699CLEARBLUE EASY EARLY RESULT PREGNANCY TESTNovember 27, 2002
K013874CLEARPLANE EASY OVULATION TESTFebruary 19, 2002
K013372CLEARBLUE EASY EARLY RESULT PREGNANCY TESTNovember 9, 2001
K993333CLEARPLAN EASY II HOME PREGNANCY TESTDecember 16, 1999
K993703CLEARVIEW EASY HCG PREGNANCY TESTDecember 2, 1999
K990262CLEARPLAN EASY HOME PREGNANCY TESTApril 7, 1999
K990223MODIFICATION OF CLEARPLAN EASY FERTILITY MONITORFebruary 24, 1999
K981946CLEARVIEW IMDecember 10, 1998
K981207CLEARPLAN EASY FERTILITY MONITOROctober 28, 1998