Selfcare, Inc.

FDA Regulatory Profile

Selfcare, Inc. appears in FDA public data with 0 recalls, 15 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Oct 12, 2000.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K002867INVERNESS MEDICAL OVULATION PREDICTOR TESTOct 12, 2000
K002134ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEMAug 7, 2000
K002049INVERNESS MEDICAL EARLY PREGNANCY TESTJul 27, 2000
K001427MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMJun 2, 2000
K000583FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMMar 17, 2000
K993632FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMNov 12, 1999
K991480EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIPSep 17, 1999
K991466EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (May 25, 1999
K991386EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)May 25, 1999
K990939FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMApr 20, 1999
K983468FASTTAKE ADAPTER, MODEL # P/N 020-072-01Dec 17, 1998
K970707ELECT II BLOOD GLUCOSE MONITORING SYSTEMJun 20, 1997
K961985ELECT BLOOD GLUCOSE MONITORIG SYSTEMSep 5, 1996
K960053SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEMJun 28, 1996
K960436SELFCARE EARLY PREGNANCY TESTMar 19, 1996