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FDA 510(k) Application Details - K180504
Device Classification Name
Enzymatic Esterase--Oxidase, Cholesterol
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510(K) Number
K180504
Device Name
Enzymatic Esterase--Oxidase, Cholesterol
Applicant
ACON Laboratories, Inc.
10125 Mesa Rim Road
San Diego, CA 92121 US
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Contact
Qiyi Xie
Other 510(k) Applications for this Contact
Regulation Number
862.1175
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Classification Product Code
CHH
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More FDA Info for this Product Code
Date Received
02/26/2018
Decision Date
03/28/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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