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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Control, Normal
510(k) Number K891179
Device Name EDL NORMAL COAGULATION CONTROL
Applicant
Elite Diagnostic , Ltd.
3244 Dogwood Cir. So. Dr.
Indianapolis,  IN  46268
Applicant Contact ROY SPECK
Correspondent
Elite Diagnostic , Ltd.
3244 Dogwood Cir. So. Dr.
Indianapolis,  IN  46268
Correspondent Contact ROY SPECK
Regulation Number864.5425
Classification Product Code
GIZ  
Date Received03/06/1989
Decision Date 04/10/1989
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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