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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K983185
Device Name BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,,  IN  46250 -0457
Applicant Contact PRISCILLA A HAMILL
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,,  IN  46250 -0457
Correspondent Contact PRISCILLA A HAMILL
Regulation Number866.5510
Classification Product Code
DGC  
Date Received09/11/1998
Decision Date 11/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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