FDA 510(k) Application Details - K983167

Device Classification Name Transferrin, Antigen, Antiserum, Control

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510(K) Number K983167
Device Name Transferrin, Antigen, Antiserum, Control
Applicant ABBOTT LABORATORIES
1920 HURD DR.
IRVING, TX 75038 US
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Contact LINDA MORRIS
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Regulation Number 866.5880

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Classification Product Code DDG
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Date Received 09/10/1998
Decision Date 11/04/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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