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FDA 510(k) Application Details - K121224
Device Classification Name
Glucose Dehydrogenase, Glucose
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510(K) Number
K121224
Device Name
Glucose Dehydrogenase, Glucose
Applicant
TaiDoc Technology Corporation
3F,5F, No.127, Wugong 2nd Rd.
Wugu District
New Taipei City 24888 TW
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Contact
LINDA KO
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Regulation Number
862.1345
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Classification Product Code
LFR
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Date Received
04/20/2012
Decision Date
09/19/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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