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Selfcare, Inc.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K002867 INVERNESS MEDICAL OVULATION PREDICTOR TESTCEP2000-10-12 View
510(k) K002134 ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEMCGA2000-08-07 View
510(k) K002049 INVERNESS MEDICAL EARLY PREGNANCY TESTLCX2000-07-27 View
510(k) K001427 MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMCGA2000-06-02 View
510(k) K000583 FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMCGA2000-03-17 View
510(k) K993632 FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMCGA1999-11-12 View
510(k) K991480 EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIPCGA1999-09-17 View
510(k) K991466 EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)CEP1999-05-25 View
510(k) K991386 EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)CEP1999-05-25 View
510(k) K990939 FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMCGA1999-04-20 View
510(k) K983468 FASTTAKE ADAPTER, MODEL # P/N 020-072-01JQP1998-12-17 View
510(k) K970707 ELECT II BLOOD GLUCOSE MONITORING SYSTEMCGA1997-06-20 View
510(k) K961985 ELECT BLOOD GLUCOSE MONITORIG SYSTEMCGA1996-09-05 View
510(k) K960053 SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEMCGA1996-06-28 View
510(k) K960436 SELFCARE EARLY PREGNANCY TESTLCX1996-03-19 View
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