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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Iga, Ferritin, Antigen, Antiserum, Control
510(k) Number K870930
Device Name TINA-QUANT(R) (A) C3
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 Number866.5510
Classification Product Code
CZM  
Date Received03/09/1987
Decision Date 03/24/1987
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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