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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K900017
Device Name REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)
Applicant
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Applicant Contact PAT FRANKS
Correspondent
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Correspondent Contact PAT FRANKS
Regulation Number864.8625
Classification Product Code
JPK  
Date Received01/02/1990
Decision Date 01/29/1990
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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