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FDA 510(k) Application Details - K173327
Device Classification Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
More FDA Info for this Device
510(K) Number
K173327
Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant
Healthy.io Ltd
27 Rothschild Boulevard
Tel Aviv 6688206 IL
Other 510(k) Applications for this Company
Contact
Ron Zohar
Other 510(k) Applications for this Contact
Regulation Number
862.1340
More FDA Info for this Regulation Number
Classification Product Code
JIL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/20/2017
Decision Date
07/18/2018
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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