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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K891370
Device Name EDL ONE-STAGE PROTHROMBIN TIME REAGENT
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 Number864.7750
Classification Product Code
GJS  
Date Received03/09/1989
Decision Date 04/21/1989
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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