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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 -0457
Applicant Contact CHERI EMMONS
Correspondent
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
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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