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510(k) K170587

On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis by ACON Laboratories, Inc. — Product Code JIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2017
Date Received
February 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitroprusside, Ketones (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1435
Review Panel
CH
Submission Type

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