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FDA 510(k) Application Details - K171861
Device Classification Name
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510(K) Number
K171861
Device Name
CAPILLARYS Hb A1c
Applicant
Sebia
1705 Corporate Drive Suite 400
Norcross, GA 30093 US
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Contact
Karen Anderson
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Regulation Number
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Classification Product Code
PDJ
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More FDA Info for this Product Code
Date Received
06/22/2017
Decision Date
02/07/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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