FDA 510(k)

精密CRP，精密Dx分析儀，精密Dx校準卡匣

K 號：K201256 · 2022-11-04

決定日期2022-11-04

產品代碼DCK

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

Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Procise Diagnostics. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K201256. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge?

Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Procise Diagnostics. The 510(k) number is K201256.

When did Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge receive FDA 510(k) clearance?

Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge received FDA 510(k) clearance on 2022-11-04, under 510(k) number K201256.

Who is the listed applicant for Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge?

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

What is the FDA product code for Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge?

The FDA product code for Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge is DCK.

相關器械（代碼：DCK）

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。

K242170K-ASSAY CRP (版本2)Kamiya Biomedical Company, LLC K192028裕米森C1200 CRPHORIBA ABX SAS K192118CRP VarioSENTINEL CH. SpA K191993裕米森C1200 CRPHORIBA ABX SAS K160712VITROS化學產品hsCRP試劑Ortho Clinical Diagnostics K142993QuikRead go CRP，QuikRead go CRP驗證組，QuikRead go CRP控制組，以及QuikRead go儀器Orion Diagnostica, OY

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。