Accumetrics, Inc. - FDA 510(k) Cleared Devices
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Accumetrics, Inc. Hematology ✕
7 devices
Cleared
Jul 24, 2015
ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
Hematology
420d
Cleared
Aug 05, 2005
VERIFYNOW-P2Y12 ASSAY
Hematology
84d
Cleared
Oct 06, 2004
VERIFYNOW-ASPIRIN ASSAY
Hematology
29d
Cleared
Jun 12, 2002
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
Hematology
302d
Cleared
May 16, 2002
MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)
Hematology
197d
Cleared
Oct 16, 2001
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
Hematology
167d
Cleared
Dec 20, 1999
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA...
Hematology
145d