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FDA 510(k)

On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis

K-Number: K170587 · 2017-07-06

ApplicantACON Laboratories, Inc.
Decision Date2017-07-06
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis is a medical device manufactured by ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2017-07-06 under approval number K170587. The device is classified under product code JIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis?

On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis is a medical device that received FDA 510(k) clearance on 2017-07-06. It is manufactured by ACON Laboratories, Inc.. The 510(k) number is K170587.

When was On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis approved by the FDA?

On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis received FDA 510(k) clearance on 2017-07-06, under approval number K170587.

What company makes On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis?

On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis is manufactured by ACON Laboratories, Inc..

What is the FDA product code for On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis?

The FDA product code for On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis is JIN.

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Related Devices (Code: JIN)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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