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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Whole Human Serum, Antigen, Antiserum, Control
510(k) Number K902220
Device Name PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
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 Number866.5700
Classification Product Code
DGR  
Date Received05/17/1990
Decision Date 09/05/1990
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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