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FDA 510(k) Application Details - K141874
Device Classification Name
Automated Urinalysis System
More FDA Info for this Device
510(K) Number
K141874
Device Name
Automated Urinalysis System
Applicant
YD DIAGNOSTICS CORP.
#821 SAMIL PLAZA
837-26 YEUKSAM-DONG
GANGNAM-GU, SEOUL 135-768 KR
Other 510(k) Applications for this Company
Contact
YANG HO DONG
Other 510(k) Applications for this Contact
Regulation Number
862.2900
More FDA Info for this Regulation Number
Classification Product Code
KQO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/11/2014
Decision Date
05/28/2015
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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