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FDA 510(k)

Gold Standard Diagnostics (GSD) AIX1000 快速血濾反應 (RPR) 自动化測試系統

K 號：K250249 · 2025-10-10

申請人Gold Standard Diagnostics, LLC
決定日期2025-10-10
產品代碼GMQ
諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)
決定相當於

器材摘要

Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System is the device name listed in this FDA 510(k) record. The listed applicant is Gold Standard Diagnostics, LLC. It received FDA 510(k) clearance on 2025-10-10 under 510(k) number K250249. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System?

Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System is a medical device that received FDA 510(k) clearance on 2025-10-10. The listed applicant is Gold Standard Diagnostics, LLC. The 510(k) number is K250249.

When did Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System receive FDA 510(k) clearance?

Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System received FDA 510(k) clearance on 2025-10-10, under 510(k) number K250249.

Who is the listed applicant for Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System?

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

What is the FDA product code for Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System?

The FDA product code for Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System is GMQ.

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。

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相關器械（代碼：GMQ）

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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