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FDA 510(k) Application Details - K050119
Device Classification Name
Immunochemical, Bence-Jones Protein
More FDA Info for this Device
510(K) Number
K050119
Device Name
Immunochemical, Bence-Jones Protein
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD.
P.O. BOX 8000, M/S W-515
BREA, CA 92822-8000 US
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Contact
KIM WALKER
Other 510(k) Applications for this Contact
Regulation Number
866.5150
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Classification Product Code
JKM
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More FDA Info for this Product Code
Date Received
01/18/2005
Decision Date
05/06/2005
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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