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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 K042423
Device Name VERIFYNOW-ASPIRIN ASSAY
Applicant
Accumetrics, Inc.
3985 Sorrento Valley Blvd.
San Diego,  CA  92121
Applicant Contact BARBARA STEVENS
Correspondent
Accumetrics, Inc.
3985 Sorrento Valley Blvd.
San Diego,  CA  92121
Correspondent Contact BARBARA STEVENS
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received09/07/2004
Decision Date 10/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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