Selfcare, Inc. is one of 21578 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Selfcare, Inc. - FDA 510(k) Cleared Devices
Recent clearances: INVERNESS MEDICAL OVULATION PREDICTOR TEST, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM, INVERNESS MEDICAL EARLY PREGNANCY TEST
15
Total
15
Cleared
0
Denied
Selfcare, Inc. has 15 FDA 510(k) cleared chemistry devices. Based in Waltham, US.
Historical record: 15 cleared submissions from 1996 to 2000.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Selfcare, Inc.
15 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
Nov 12, 1999
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
Immunology
16d
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