FDA 510(k) Application Details - K963427

Device Classification Name Transferrin, Antigen, Antiserum, Control

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510(K) Number K963427
Device Name Transferrin, Antigen, Antiserum, Control
Applicant BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA, CA 92622-8000 US
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Contact MARGIE GEORGE
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Regulation Number 866.5880

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Classification Product Code DDG
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Date Received 08/30/1996
Decision Date 10/07/1996
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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