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Selfcare, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K002867INVERNESS MEDICAL OVULATION PREDICTOR TESTOctober 12, 2000
K002134ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEMAugust 7, 2000
K002049INVERNESS MEDICAL EARLY PREGNANCY TESTJuly 27, 2000
K001427MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMJune 2, 2000
K000583FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMMarch 17, 2000
K993632FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMNovember 12, 1999
K991480EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIPSeptember 17, 1999
K991386EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)May 25, 1999
K991466EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (May 25, 1999
K990939FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMApril 20, 1999
K983468FASTTAKE ADAPTER, MODEL # P/N 020-072-01December 17, 1998
K970707ELECT II BLOOD GLUCOSE MONITORING SYSTEMJune 20, 1997
K961985ELECT BLOOD GLUCOSE MONITORIG SYSTEMSeptember 5, 1996
K960053SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEMJune 28, 1996
K960436SELFCARE EARLY PREGNANCY TESTMarch 19, 1996