FDA 510(k)

QUANTA Flash Jo-1，QUANTA Flash Jo-1校準器，以及QUANTA Flash Jo-1控制組

K 號：K151429 · 2016-02-12

決定日期2016-02-12

產品代碼LLL

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

QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K151429. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols?

QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K151429.

When did QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols receive FDA 510(k) clearance?

QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols received FDA 510(k) clearance on 2016-02-12, under 510(k) number K151429.

Who is the listed applicant for QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols?

The FDA 510(k) record lists Inova Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols?

The FDA product code for QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols is LLL.

其他以 Inova Diagnostics, Inc. 為申請人之記錄

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相關器械（代碼：LLL）

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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