FDA 510(k)

Distinct® 預早檢測懷孕試劑

K 號：K193318 · 2020-08-20

決定日期2020-08-20

產品代碼LCX

諮詢委員會CH

決定相當於

器材摘要

Distinct® Early Detection Pregnancy Test 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 2020-08-20 under 510(k) number K193318. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Distinct® Early Detection Pregnancy Test?

Distinct® Early Detection Pregnancy Test is a medical device that received FDA 510(k) clearance on 2020-08-20. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K193318.

When did Distinct® Early Detection Pregnancy Test receive FDA 510(k) clearance?

Distinct® Early Detection Pregnancy Test received FDA 510(k) clearance on 2020-08-20, under 510(k) number K193318.

Who is the listed applicant for Distinct® Early Detection Pregnancy Test?

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 Distinct® Early Detection Pregnancy Test?

The FDA product code for Distinct® Early Detection Pregnancy Test is LCX.

其他以 ACON Laboratories, Inc. 為申請人之記錄

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K261212Flowflex Plus RSV + 流行性感冒A/B + COVID 快速檢測 K251697Flowflex® Plus 醍醐A 快速測試條；Flowflex® Plus 醍醐A 快速測試卡 K251749Flowflex Plus RSV + 流行性感冒A/B + COVID家庭檢測 K250085On Call® 確保 GK 血糖與酮體監測系統；On Call® 確保同步 GK 血糖與酮體監測系統 K250377Flowflex Plus COVID-19 + 流感A/B 家庭檢測 K232715Distinct®數位懷孕檢測器

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相關器械（代碼：LCX）

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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