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FDA 510(k) Application Details - K100304
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K100304
Device Name
Assay, Glycosylated Hemoglobin
Applicant
Tosoh BioScience, Inc.
6000 SHORELINE COURT
SUITE 101
SOUTH SAN FRANCISCO, CA 94080 US
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Contact
Judith Ogden
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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
02/03/2010
Decision Date
08/27/2010
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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