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FDA 510(k) Application Details - K002930
Device Classification Name
Reagent, Occult Blood
More FDA Info for this Device
510(K) Number
K002930
Device Name
Reagent, Occult Blood
Applicant
MEDTEK DIAGNOSTICS, LLC.
PO BOX 14125
RESEARCH TRIANGLE PARK, NC 27709-4125 US
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Contact
LIANE F GOSSET
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
09/20/2000
Decision Date
01/22/2001
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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