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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 K992531
Device Name ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM
Applicant
ACCUMETRICS, INC.
3985 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Applicant Contact FRANCES E HARRISON
Correspondent
ACCUMETRICS, INC.
3985 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact FRANCES E HARRISON
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received07/28/1999
Decision Date 12/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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