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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, Fitc, Antigen, Antiserum, Control
510(k) Number K871027
Device Name PRECINORM(R) PROTEIN
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact CHERI EMMONS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact CHERI EMMONS
Regulation Number866.5510
Classification Product Code
DAF  
Date Received03/16/1987
Decision Date 05/15/1987
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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