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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K853722
Device Name PLT-4 PLATELET ANALYZER
Applicant
Texas Intl. Laboratories, Inc.
5601 Bintliff
Suite 500
Houston,  TX  77036
Applicant Contact ROBERT P COGAN
Correspondent
Texas Intl. Laboratories, Inc.
5601 Bintliff
Suite 500
Houston,  TX  77036
Correspondent Contact ROBERT P COGAN
Regulation Number864.5200
Classification Product Code
GKL  
Date Received09/05/1985
Decision Date 01/17/1986
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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