FDA 510(k)

類固醇21-氫氧酶抗體（21-OHAb）ELISA試劑套件

K 號：K180607 · 2018-11-23

決定日期2018-11-23

產品代碼PCG

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

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit is the device name listed in this FDA 510(k) record. The listed applicant is Kronus, Inc.. It received FDA 510(k) clearance on 2018-11-23 under 510(k) number K180607. The device is classified under product code PCG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit?

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit is a medical device that received FDA 510(k) clearance on 2018-11-23. The listed applicant is Kronus, Inc.. The 510(k) number is K180607.

When did Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit receive FDA 510(k) clearance?

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit received FDA 510(k) clearance on 2018-11-23, under 510(k) number K180607.

Who is the listed applicant for Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit?

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

What is the FDA product code for Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit?

The FDA product code for Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit is PCG.

其他以 Kronus, Inc. 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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