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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gamma Globulin, Antigen, Antiserum, Control
510(k) Number K931247
Device Name TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067
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
DAH  
Date Received03/11/1993
Decision Date 04/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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