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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoelectrophoretic, Immunoglobulins, (G, A, M)
510(k) Number K990998
Device Name POLYSLIT IFE KIT
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 Number866.5510
Classification Product Code
CFF  
Date Received03/25/1999
Decision Date 06/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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