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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Fitc, Antigen, Antiserum, Control
510(k) Number K931224
Device Name VIDAS TOTAL IGE (IGE) ASSAY
Applicant
Biomerieux Vitek, Inc.
1022 Hingham St.
Rockland,  MA  02370
Applicant Contact VICKI ANASTASI
Correspondent
Biomerieux Vitek, Inc.
1022 Hingham St.
Rockland,  MA  02370
Correspondent Contact VICKI ANASTASI
Regulation Number866.5510
Classification Product Code
DGP  
Date Received03/10/1993
Decision Date 05/20/1993
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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