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FDA 510(k) Application Details - K041297
Device Classification Name
Reagent, Occult Blood
More FDA Info for this Device
510(K) Number
K041297
Device Name
Reagent, Occult Blood
Applicant
POLYMEDCO, INC.
510 FURNACE DOCK RD.
CORTLANDT MANOR, NY 10567 US
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Contact
HELEN LANDICHO
Other 510(k) Applications for this Contact
Regulation Number
864.6550
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Classification Product Code
KHE
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More FDA Info for this Product Code
Date Received
05/14/2004
Decision Date
08/12/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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