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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 K880566
Device Name CLP PROTHROMBIN TIME TEST
Applicant
CREATIVE LABORATORY PRODUCTS, INC.
6258 LA PAS TRAIL
INDIANAPOLIS,  IN  46268
Applicant Contact ROY SPECK
Correspondent
CREATIVE LABORATORY PRODUCTS, INC.
6258 LA PAS TRAIL
INDIANAPOLIS,  IN  46268
Correspondent Contact ROY SPECK
Regulation Number864.7750
Classification Product Code
GJS  
Date Received02/10/1988
Decision Date 03/23/1988
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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