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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 K032796
Device Name IBL C3D-CIC EIA TEST
Applicant
Ibl GmbH
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301
Applicant Contact Gary Lehnus
Correspondent
Ibl GmbH
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301
Correspondent Contact Gary Lehnus
Regulation Number866.5240
Classification Product Code
CZW  
Date Received09/08/2003
Decision Date 01/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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