Medical Device Manufacturer · US , Waltham , MA

Selfcare, Inc.

15 submissions · 15 cleared · Since 1996
15
Total
15
Cleared
0
Denied

Selfcare, Inc. — FDA 510(k) Submissions

Selfcare, Inc. has submitted 15 FDA 510(k) premarket notifications since 1996, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Glucose Oxidase, Glucose, Radioimmunoassay, Luteinizing Hormone, Kit, Test, Pregnancy, Hcg, Over The Counter, Calculator/data Processing Module, For Clinical Use . Use the specialty filter in the sidebar to narrow results.

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