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FDA 510(k) Application Details - K222921
Device Classification Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
More FDA Info for this Device
510(K) Number
K222921
Device Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Applicant
Healthy.io Ltd.
8 Yitzhak Sadeh Street
Tel Aviv 6777508 IL
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Contact
Ron Zohar
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Regulation Number
862.1645
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Classification Product Code
JIR
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More FDA Info for this Product Code
Date Received
09/26/2022
Decision Date
09/08/2023
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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