FDA 510(k)

即時酮體試劑條，用於尿液化驗；健康我酮體試劑條，用於尿液化驗

K 號：K170587 · 2017-07-06

決定日期2017-07-06

產品代碼JIN

諮詢委員會CH

決定相當於

器材摘要

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

常見問題

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. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K170587.

When did On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis receive FDA 510(k) clearance?

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

Who is the listed applicant for On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis?

The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

其他以 ACON Laboratories, Inc. 為申請人之記錄

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相關器械（代碼：JIN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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