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FDA 510(k) Application Details - K080618
Device Classification Name
Assay, Glycosylated Hemoglobin
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510(K) Number
K080618
Device Name
Assay, Glycosylated Hemoglobin
Applicant
JAS Diagnostics, Inc.
7220 NW 58TH ST.
MIAMI, FL 33166 US
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Contact
SAMUEL BURGOS
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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
03/05/2008
Decision Date
05/23/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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