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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K881113
Device Name CLP LIPOPROTEIN ELECTROPHORESIS 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 Number862.1660
Classification Product Code
JJY  
Date Received03/15/1988
Decision Date 07/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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