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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C3, Antigen, Antiserum, Control
510(k) Number K962199
Device Name QUANTEX C3
Applicant
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
LEXINGTON,  MA  02173
Applicant Contact BETTY J LANE
Correspondent
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
LEXINGTON,  MA  02173
Correspondent Contact BETTY J LANE
Regulation Number866.5240
Classification Product Code
CZW  
Date Received06/07/1996
Decision Date 09/25/1996
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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