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FDA 510(k)

Multichem IA Plus

K 號：K162530 · 2017-03-31

申請人Techno-Path Manufacturing
決定日期2017-03-31
產品代碼JJY
諮詢委員會CH
決定相當於

器材摘要

Multichem IA Plus is the device name listed in this FDA 510(k) record. The listed applicant is Techno-Path Manufacturing. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K162530. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Multichem IA Plus?

Multichem IA Plus is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Techno-Path Manufacturing. The 510(k) number is K162530.

When did Multichem IA Plus receive FDA 510(k) clearance?

Multichem IA Plus received FDA 510(k) clearance on 2017-03-31, under 510(k) number K162530.

Who is the listed applicant for Multichem IA Plus?

The FDA 510(k) record lists Techno-Path Manufacturing as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multichem IA Plus?

The FDA product code for Multichem IA Plus is JJY.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：JJY）

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。

K163629Audit MicroControls Linearity FD 癌症標記IIAalto Scientific, Ltd.K163015Liquichek 癌症標記控制級別 1；Liquichek 癌症標記控制級別 2；Liquichek 癌症標記控制級別 3；Liquichek 癌症標記控制- 三級 MiniPakBio-Rad LaboratoriesK153712VK-3驗證套件、VK-4驗證套件、VK-R5驗證套件、VK-R7驗證套件、VK-Crea驗證套件Radiometer America, Inc.

官方來源

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