FDA 510(k)

hCG單步懷孕檢測

K 號：K212418 · 2022-06-30

決定日期2022-06-30

產品代碼LCX

諮詢委員會CH

決定相當於

器材摘要

hCG One Step Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is Healstone Biotech, Inc.. It received FDA 510(k) clearance on 2022-06-30 under 510(k) number K212418. 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 hCG One Step Pregnancy Test?

hCG One Step Pregnancy Test is a medical device that received FDA 510(k) clearance on 2022-06-30. The listed applicant is Healstone Biotech, Inc.. The 510(k) number is K212418.

When did hCG One Step Pregnancy Test receive FDA 510(k) clearance?

hCG One Step Pregnancy Test received FDA 510(k) clearance on 2022-06-30, under 510(k) number K212418.

Who is the listed applicant for hCG One Step Pregnancy Test?

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

What is the FDA product code for hCG One Step Pregnancy Test?

The FDA product code for hCG One Step Pregnancy Test is LCX.

其他以 Healstone Biotech, Inc. 為申請人之記錄

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。

K221871Healstone Accurate (TM) 滲潛用藥物尿液檢測杯，Healstone Accurate (TM) 滲潛用藥物尿液檢測杯藥局處方 K191841Accurate Multi Panel 药物尿液檢測杯

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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