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FDA 510(k) Application Details - K963868
Device Classification Name
Igg, Antigen, Antiserum, Control
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510(K) Number
K963868
Device Name
Igg, 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
ANNETTE HELLIE
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Regulation Number
866.5510
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Classification Product Code
DEW
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More FDA Info for this Product Code
Date Received
09/26/1996
Decision Date
02/10/1997
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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