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FDA 510(k) Application Details - K041764
Device Classification Name
Assay, Glycosylated Hemoglobin
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510(K) Number
K041764
Device Name
Assay, Glycosylated Hemoglobin
Applicant
ORTHO-CLINICAL DIAGNOSTICS
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101 US
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Contact
CAREY A MAYO
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Regulation Number
864.7470
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Classification Product Code
LCP
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More FDA Info for this Product Code
Date Received
06/30/2004
Decision Date
09/09/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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