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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 K883177
Device Name H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER
Applicant
Texas Intl. Laboratories, Inc.
5601 Bintliff
Suite 500
Houston,  TX  77036
Applicant Contact ROBERT COGAN
Correspondent
Texas Intl. Laboratories, Inc.
5601 Bintliff
Suite 500
Houston,  TX  77036
Correspondent Contact ROBERT COGAN
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received07/27/1988
Decision Date 11/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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