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FDA 510(k) Application Details - K071346
Device Classification Name
Radioassay, Intrinsic Factor Blocking Antibody
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510(K) Number
K071346
Device Name
Radioassay, Intrinsic Factor Blocking Antibody
Applicant
IMMCO DIAGNOSTICS, INC.
60 PINEVIEW DR.
BUFFALO, NY 14228-2120 US
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Contact
KEVIN LAWSON
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Regulation Number
862.1810
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Classification Product Code
LIG
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Date Received
05/14/2007
Decision Date
09/24/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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