FDA 510(k) Applications Submitted by KATHLEEN STORRO
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K000318 |
02/01/2000 |
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM |
BIONOSTICS, INC. |
K050961 |
04/18/2005 |
RNA1C CONTROL FOR NYCOCARD HBA1C |
BIONOSTICS, INC. |
K021624 |
05/16/2002 |
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 |
BIONOSTICS, INC. |
K021697 |
05/22/2002 |
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE |
BIONOSTICS, INC. |
K081478 |
05/27/2008 |
RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS |
BIONOSTICS, INC. |
K032453 |
08/11/2003 |
ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL |
BIONOSTICS, INC. |
K002540 |
08/16/2000 |
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS |
BIONOSTICS, INC. |
K082395 |
08/19/2008 |
GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 |
BIONOSTICS, INC. |
K022769 |
08/21/2002 |
LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION |
BIONOSTICS, INC. |
K032819 |
09/10/2003 |
GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM |
BIONOSTICS, INC. |
K053327 |
12/01/2005 |
OXICOM CONTROL |
BIONOSTICS, INC. |
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