FDA 510(k)

Aptima 阴道毛滴虫檢測試劑

K 號：K231316 · 2023-11-06

決定日期2023-11-06

產品代碼OUY

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

Aptima Trichomonas vaginalis Assay is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2023-11-06 under 510(k) number K231316. The device is classified under product code OUY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aptima Trichomonas vaginalis Assay?

Aptima Trichomonas vaginalis Assay is a medical device that received FDA 510(k) clearance on 2023-11-06. The listed applicant is Hologic, Inc.. The 510(k) number is K231316.

When did Aptima Trichomonas vaginalis Assay receive FDA 510(k) clearance?

Aptima Trichomonas vaginalis Assay received FDA 510(k) clearance on 2023-11-06, under 510(k) number K231316.

Who is the listed applicant for Aptima Trichomonas vaginalis Assay?

FDA 510(k) 記錄將霍洛基克公司（Hologic, Inc.）列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Aptima Trichomonas vaginalis Assay?

The FDA product code for Aptima Trichomonas vaginalis Assay is OUY.