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FDA 510(k) Application Details - K033603
Device Classification Name
Radioassay, Intrinsic Factor Blocking Antibody
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510(K) Number
K033603
Device Name
Radioassay, Intrinsic Factor Blocking Antibody
Applicant
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318-1084 US
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Contact
VALYNDA MACHEN
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Regulation Number
862.1810
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Classification Product Code
LIG
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Date Received
11/17/2003
Decision Date
12/19/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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