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FDA 510(k) Application Details - K040146
Device Classification Name
Abnormal Hemoglobin Quantitation
More FDA Info for this Device
510(K) Number
K040146
Device Name
Abnormal Hemoglobin Quantitation
Applicant
INTERLAB S.R.L.
150 CHERRY LANE RD.
EAST STROUDSBURG, PA 18301-8804 US
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Contact
Gary Lehnus
Other 510(k) Applications for this Contact
Regulation Number
864.7415
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Classification Product Code
GKA
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More FDA Info for this Product Code
Date Received
01/22/2004
Decision Date
05/04/2004
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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