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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
Applicant
QUANTIMETRIX CORP.
2005 MANHATTAN BEACH BLVD.
REDONDO BEACH,  CA  90278 -1205
Applicant Contact EVA LASZLO
Correspondent
QUANTIMETRIX CORP.
2005 MANHATTAN BEACH BLVD.
REDONDO BEACH,  CA  90278 -1205
Correspondent Contact EVA LASZLO
Regulation Number864.8625
Classification Product Code
JPK  
Date Received02/28/2001
Decision Date 03/23/2001
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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