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FDA 510(k) Application Details - K011933
Device Classification Name
Assay, Glycosylated Hemoglobin
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510(K) Number
K011933
Device Name
Assay, Glycosylated Hemoglobin
Applicant
PROVALIS DIAGNOSTICS LTD.
16809 BRIARDALE RD.
ROCKVILLE, MD 20855 US
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Contact
THOMAS M TSAKERIS
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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
06/20/2001
Decision Date
11/02/2001
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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