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FDA 510(k) Application Details - K974564
Device Classification Name
Alpha-2-Macroglobulin, Antigen, Antiserum, Control
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510(K) Number
K974564
Device Name
Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-104
BREA, CA 92621 US
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Contact
ANNETTE HELLIE
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Regulation Number
866.5620
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Classification Product Code
DEB
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More FDA Info for this Product Code
Date Received
12/05/1997
Decision Date
02/17/1998
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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