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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 K880712
Device Name CLP NORMAL COAGULATION CONTROL
Applicant
Creative Laboratory Products, Inc.
6258 La Pas Trl.
Indianapolis,  IN  46268
Applicant Contact ROY SPECK
Correspondent
Creative Laboratory Products, Inc.
6258 La Pas Trl.
Indianapolis,  IN  46268
Correspondent Contact ROY SPECK
Regulation Number864.5425
Classification Product Code
GIZ  
Date Received02/22/1988
Decision Date 05/06/1988
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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