Medical Device Manufacturer · US , Waltham , MA

Selfcare, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1996
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
1-15 of 15
Cleared Oct 12, 2000
INVERNESS MEDICAL OVULATION PREDICTOR TEST
K002867 · CEP
Chemistry · 29d
Cleared Aug 07, 2000
ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K002134 · CGA
Chemistry · 24d
Cleared Jul 27, 2000
INVERNESS MEDICAL EARLY PREGNANCY TEST
K002049 · LCX
Chemistry · 24d
Cleared Jun 02, 2000
MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K001427 · CGA
Chemistry · 28d
Cleared Mar 17, 2000
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K000583 · CGA
Chemistry · 24d
Cleared Nov 12, 1999
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K993632 · CGA
Immunology · 16d
Cleared Sep 17, 1999
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
K991480 · CGA
Chemistry · 142d
Cleared May 25, 1999
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK),...
K991386 · CEP
Chemistry · 34d
Cleared May 25, 1999
EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR...
K991466 · CEP
Chemistry · 28d
Cleared Apr 20, 1999
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K990939 · CGA
Chemistry · 29d
Cleared Dec 17, 1998
FASTTAKE ADAPTER, MODEL # P/N 020-072-01
K983468 · JQP
Chemistry · 77d
Cleared Jun 20, 1997
ELECT II BLOOD GLUCOSE MONITORING SYSTEM
K970707 · CGA
Chemistry · 114d
Cleared Sep 05, 1996
ELECT BLOOD GLUCOSE MONITORIG SYSTEM
K961985 · CGA
Chemistry · 107d
Cleared Jun 28, 1996
SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM
K960053 · CGA
Chemistry · 176d
Cleared Mar 19, 1996
SELFCARE EARLY PREGNANCY TEST
K960436 · LCX
Chemistry · 48d
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