FDA 510(k)

Alltest懷孕快速組合測試條

K 號：K203272 · 2022-01-31

決定日期2022-01-31

產品代碼JHI

諮詢委員會CH

決定相當於

器材摘要

Alltest Pregnancy Rapid Combo Test Cassette is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2022-01-31 under 510(k) number K203272. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alltest Pregnancy Rapid Combo Test Cassette?

Alltest Pregnancy Rapid Combo Test Cassette is a medical device that received FDA 510(k) clearance on 2022-01-31. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K203272.

When did Alltest Pregnancy Rapid Combo Test Cassette receive FDA 510(k) clearance?

Alltest Pregnancy Rapid Combo Test Cassette received FDA 510(k) clearance on 2022-01-31, under 510(k) number K203272.

Who is the listed applicant for Alltest Pregnancy Rapid Combo Test Cassette?

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

What is the FDA product code for Alltest Pregnancy Rapid Combo Test Cassette?

The FDA product code for Alltest Pregnancy Rapid Combo Test Cassette is JHI.

其他以 Hangzhou AllTest Biotech Co., Ltd. 為申請人之記錄

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相關器械（代碼：JHI）

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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