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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name counter, differential cell
510(k) Number K971736
Device Name SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER
Applicant
SYSMEX CORP.
GILMER RD.
6699 RFD
LONG GROVE,  IL  60047 -9596
Applicant Contact CATHERINE M TRESTER
Correspondent
SYSMEX CORP.
GILMER RD.
6699 RFD
LONG GROVE,  IL  60047 -9596
Correspondent Contact CATHERINE M TRESTER
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received05/12/1997
Decision Date 08/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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