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FDA 510(k) Application Details - K991850
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K991850
Device Name
Assay, Glycosylated Hemoglobin
Applicant
BIOSAFE LABORATORIES, INC.
300 KNIGHTSBRIDGE PKWY., #150
LINCOLNSHIRE, IL 60069 US
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Contact
STEVEN P TYRRELL
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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
06/01/1999
Decision Date
11/26/1999
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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