FDA 510(k) Applications Submitted by ACCUMETRICS, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K051231 |
05/13/2005 |
VERIFYNOW-P2Y12 ASSAY |
ACCUMETRICS, INC. |
K042423 |
09/07/2004 |
VERIFYNOW-ASPIRIN ASSAY |
ACCUMETRICS, INC. |
K992531 |
07/28/1999 |
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM |
ACCUMETRICS, INC. |
K141427 |
05/30/2014 |
ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST |
ACCUMETRICS, INC. |
K011337 |
05/02/2001 |
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) |
ACCUMETRICS, INC. |
K012701 |
08/14/2001 |
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) |
ACCUMETRICS, INC. |
K013596 |
10/31/2001 |
MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) |
ACCUMETRICS, INC. |
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