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FDA 510(k) Application Details - K080003
Device Classification Name
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
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510(K) Number
K080003
Device Name
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Applicant
BINAX, INC.
10 SOUTHGATE RD.
SCARBOROUGH, ME 04074 US
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Contact
Anne Jepson
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Regulation Number
864.7360
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Classification Product Code
JBF
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More FDA Info for this Product Code
Date Received
01/02/2008
Decision Date
10/23/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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