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FDA 510(k)

鈣- cresol 磷膽鹼，葡萄糖，尿素/血尿素氮-紫外光

K 號：K192730 · 2020-09-09

申請人Biosystems S.A.
決定日期2020-09-09
產品代碼CHW
諮詢委員會CH
決定相當於

器材摘要

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV is the device name listed in this FDA 510(k) record. The listed applicant is Biosystems S.A.. It received FDA 510(k) clearance on 2020-09-09 under 510(k) number K192730. The device is classified under product code CHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV?

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV is a medical device that received FDA 510(k) clearance on 2020-09-09. The listed applicant is Biosystems S.A.. The 510(k) number is K192730.

When did CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV receive FDA 510(k) clearance?

CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV received FDA 510(k) clearance on 2020-09-09, under 510(k) number K192730.

Who is the listed applicant for CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV?

The FDA 510(k) record lists Biosystems S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV?

The FDA product code for CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV is CHW.

相關臨床試驗

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其他以 Biosystems S.A. 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。

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