FDA 510(k)

hCG 尿試紙，hCG 尿試條，hCG 尿試中間試紙

K 號：K200133 · 2020-08-13

申請人Safecare Biotech (Hangzhou) Co., Ltd.

決定日期2020-08-13

產品代碼LCX

諮詢委員會CH

決定相當於

器材摘要

hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-08-13 under 510(k) number K200133. 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 Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream?

hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream is a medical device that received FDA 510(k) clearance on 2020-08-13. The listed applicant is Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K200133.

When did hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream receive FDA 510(k) clearance?

hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream received FDA 510(k) clearance on 2020-08-13, under 510(k) number K200133.

Who is the listed applicant for hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream?

The FDA 510(k) record lists Safecare Biotech (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream?

The FDA product code for hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream is LCX.

其他以 Safecare Biotech (Hangzhou) Co., Ltd. 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。

K242767Safecare 尿路感染檢測器 K240654SAFECARE 藥物濾尿試條；SAFECARE FYL 濾尿試條 K202453SAFECARE多藥尿液檢測杯，SAFECARE多藥尿液檢測濾卡 K201120SAFECARE多藥尿液檢測杯，SAFECARE多藥尿液檢測濾紙卡 K191924SAFECARE® THC 肾上腺素尿液試條檢測 K182654SAFECARE多藥尿液檢測杯，SAFECARE多藥尿液檢測濾紙卡

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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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官方來源

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