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FDA 510(k) Application Details - K955087
Device Classification Name
Assay, Glycosylated Hemoglobin
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510(K) Number
K955087
Device Name
Assay, Glycosylated Hemoglobin
Applicant
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
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Contact
GABRIEL J MURACA, JR.
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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
11/07/1995
Decision Date
06/13/1996
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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