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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K896334
Device Name CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER
Applicant
Creative Laboratory Products, Inc.
6258 La Pas Trl.
Indianapolis,  IN  46268
Applicant Contact PROKSCH, PHD
Correspondent
Creative Laboratory Products, Inc.
6258 La Pas Trl.
Indianapolis,  IN  46268
Correspondent Contact PROKSCH, PHD
Regulation Number864.7470
Classification Product Code
LCP  
Date Received11/03/1989
Decision Date 12/11/1989
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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