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FDA 510(k) Application Details - K041202
Device Classification Name
Reagent, Occult Blood
More FDA Info for this Device
510(K) Number
K041202
Device Name
Reagent, Occult Blood
Applicant
W.H.P.M., INC.
163 CABOT ST.
BEVERLY, MA 01915 US
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Contact
FRAN WHITE
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
05/07/2004
Decision Date
08/12/2004
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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