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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mixture, hematology quality control
510(k) Number K010598
Device Name SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
Original Applicant
QUANTIMETRIX CORP.
2005 manhattan beach blvd.
redondo beach,  CA  90278 1205
Original Contact eva laszlo
Regulation Number864.8625
Classification Product Code
JPK  
Date Received02/28/2001
Decision Date 03/23/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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