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FDA 510(k) Application Details - K061841
Device Classification Name
Radioassay, Intrinsic Factor Blocking Antibody
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510(K) Number
K061841
Device Name
Radioassay, Intrinsic Factor Blocking Antibody
Applicant
INOVA DIAGNOSTICS, INC.
9900 OLD GROVE RD.
SAN DIEGO, CA 92131-1638 US
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Contact
GARY L NORMAN
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Regulation Number
862.1810
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Classification Product Code
LIG
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More FDA Info for this Product Code
Date Received
06/29/2006
Decision Date
12/22/2006
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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