FDA 510(k)

SPIFE A1AT 套件

K 號：K213396 · 2022-10-13

決定日期2022-10-13

產品代碼OBZ

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

SPIFE A1AT kit is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories, Corp.. It received FDA 510(k) clearance on 2022-10-13 under 510(k) number K213396. The device is classified under product code OBZ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SPIFE A1AT kit?

SPIFE A1AT kit is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Helena Laboratories, Corp.. The 510(k) number is K213396.

When did SPIFE A1AT kit receive FDA 510(k) clearance?

SPIFE A1AT kit received FDA 510(k) clearance on 2022-10-13, under 510(k) number K213396.

Who is the listed applicant for SPIFE A1AT kit?

The FDA 510(k) record lists Helena Laboratories, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIFE A1AT kit?

The FDA product code for SPIFE A1AT kit is OBZ.

其他以 Helena Laboratories, Corp. 為申請人之記錄

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