FDA 510(k) Applications Submitted by CAROL A ADILETTO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K990939 |
03/22/1999 |
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM |
SELFCARE, INC. |
| K991386 |
04/21/1999 |
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) |
SELFCARE, INC. |
| K991466 |
04/27/1999 |
EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) |
SELFCARE, INC. |
| K991480 |
04/28/1999 |
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP |
SELFCARE, INC. |
| K993632 |
10/27/1999 |
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM |
SELFCARE, INC. |
| K093758 |
12/07/2009 |
BGM GALECTIN -3 |
BG MEDICINE, INC. |
| K960053 |
01/04/1996 |
SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM |
SELFCARE, INC. |
| K000583 |
02/22/2000 |
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM |
SELFCARE, INC. |
| K001427 |
05/05/2000 |
MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM |
SELFCARE, INC. |
| K011479 |
05/14/2001 |
ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM |
INVERNESS MEDICAL INNOVATIONS, INC. |
| K961985 |
05/21/1996 |
ELECT BLOOD GLUCOSE MONITORIG SYSTEM |
SELFCARE, INC. |
| K011616 |
05/25/2001 |
INDUO BLOOD GLUCOSE METER |
INVERNESS MEDICAL INNOVATIONS, INC. |
| K002049 |
07/03/2000 |
INVERNESS MEDICAL EARLY PREGNANCY TEST |
SELFCARE, INC. |
| K002867 |
09/13/2000 |
INVERNESS MEDICAL OVULATION PREDICTOR TEST |
SELFCARE, INC. |
| K970707 |
02/26/1997 |
ELECT II BLOOD GLUCOSE MONITORING SYSTEM |
SELFCARE, INC. |
| K002134 |
07/14/2000 |
ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM |
SELFCARE, INC. |
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