FDA 510(k)

Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

K-Nummer: K250249 · 2025-10-10

AntragstellerGold Standard Diagnostics, LLC

Entscheidungsdatum2025-10-10

ProduktcodeGMQ

BeratungsausschussMI

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: GMQ)

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