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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, automated platelet aggregation
510(k) Number K011337
Device Name ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
Applicant
ACCUMETRICS, INC.
3985 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Applicant Contact RHONDA MOE
Correspondent
ACCUMETRICS, INC.
3985 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact RHONDA MOE
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received05/02/2001
Decision Date 10/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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