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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent & Control, Partial Thromboplastin Time
510(k) Number K881999
Device Name PLATELIN(R) EXCEL L
Applicant
Organon Teknika Corp.
800 Capitola Dr.
Durham,  NC  27713
Applicant Contact TONI M STIFANO
Correspondent
Organon Teknika Corp.
800 Capitola Dr.
Durham,  NC  27713
Correspondent Contact TONI M STIFANO
Regulation Number864.7925
Classification Product Code
GIT  
Date Received05/12/1988
Decision Date 08/17/1988
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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