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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation, Automated
510(k) Number K881281
Device Name COAG-A-MATE(R) XM
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 Number864.5400
Classification Product Code
GKP  
Date Received03/25/1988
Decision Date 05/18/1988
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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