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FDA 510(k) Application Details - K123986
Device Classification Name
Immunoassay, Insulin-Like Growth Factor Binding Protein-1
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510(K) Number
K123986
Device Name
Immunoassay, Insulin-Like Growth Factor Binding Protein-1
Applicant
ALERE SCARBOROUGH, INC
10 Southgate Road
Scarborough, ME 04074 US
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Contact
Angela Drysdale
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Regulation Number
862.1550
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Classification Product Code
OAM
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Date Received
12/26/2012
Decision Date
01/09/2014
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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