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FDA 510(k) Application Details - K070083
Device Classification Name
Antibodies, Gliadin
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510(K) Number
K070083
Device Name
Antibodies, Gliadin
Applicant
INOVA DIAGNOSTICS, INC.
9900 OLD GROVE RD.
SAN DIEGO, CA 92131-1638 US
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Contact
BRYS C MYERS
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Regulation Number
866.5750
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Classification Product Code
MST
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More FDA Info for this Product Code
Date Received
01/09/2007
Decision Date
03/12/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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