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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm (Mu Chain Specific), Antigen, Antiserum, Control
510(k) Number K982639
Device Name SPIFE URINE IFE
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 Number866.5550
Classification Product Code
DAO  
Date Received07/29/1998
Decision Date 11/04/1998
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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