Selfcare, Inc. - FDA 510(k) Cleared Devices
Recent clearances: EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP, EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK), EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Selfcare, Inc. Chemistry ✕
14 devices
Cleared
Oct 12, 2000
INVERNESS MEDICAL OVULATION PREDICTOR TEST
Chemistry
29d
Cleared
Aug 07, 2000
ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
24d
Cleared
Jul 27, 2000
INVERNESS MEDICAL EARLY PREGNANCY TEST
Chemistry
24d
Cleared
Jun 02, 2000
MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
28d
Cleared
Mar 17, 2000
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
24d
Cleared
Sep 17, 1999
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
Chemistry
142d
Cleared
May 25, 1999
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK),...
Chemistry
34d
Cleared
May 25, 1999
EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR...
Chemistry
28d
Cleared
Apr 20, 1999
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
29d
Cleared
Dec 17, 1998
FASTTAKE ADAPTER, MODEL # P/N 020-072-01
Chemistry
77d
Cleared
Jun 20, 1997
ELECT II BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
114d
Cleared
Sep 05, 1996
ELECT BLOOD GLUCOSE MONITORIG SYSTEM
Chemistry
107d
Cleared
Jun 28, 1996
SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM
Chemistry
176d
Cleared
Mar 19, 1996
SELFCARE EARLY PREGNANCY TEST
Chemistry
48d