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FDA 510(k) Application Details - K964762
Device Classification Name
Ceruloplasmin, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K964762
Device Name
Ceruloplasmin, 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
Other 510(k) Applications for this Contact
Regulation Number
866.5210
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Classification Product Code
DDB
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More FDA Info for this Product Code
Date Received
11/27/1996
Decision Date
04/25/1997
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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