FDA 510(k)

Maverick診斷系統TC1000; Maverick測試面板A0.B0

K 號：K234091 · 2024-07-22

決定日期2024-07-22

產品代碼JLW

諮詢委員會CH

決定相當於

器材摘要

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is the device name listed in this FDA 510(k) record. The listed applicant is Genalyte, Inc.. It received FDA 510(k) clearance on 2024-07-22 under 510(k) number K234091. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0?

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is a medical device that received FDA 510(k) clearance on 2024-07-22. The listed applicant is Genalyte, Inc.. The 510(k) number is K234091.

When did Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 receive FDA 510(k) clearance?

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 received FDA 510(k) clearance on 2024-07-22, under 510(k) number K234091.

Who is the listed applicant for Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0?

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

What is the FDA product code for Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0?

The FDA product code for Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 is JLW.

其他以 Genalyte, 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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相關器械（代碼：JLW）

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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官方來源

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