FDA 510(k)

SISTEMA DE ANÁLISE DE URINA AUTION MAX AX-4060

Número K: K193514 · 2023-04-13

Data da decisão2023-04-13

Código do produtoJIL

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

AUTION MAX AX-4060 Urinalysis System is the device name listed in this FDA 510(k) record. The listed applicant is Arkray, Inc.. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K193514. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AUTION MAX AX-4060 Urinalysis System?

AUTION MAX AX-4060 Urinalysis System is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Arkray, Inc.. The 510(k) number is K193514.

When did AUTION MAX AX-4060 Urinalysis System receive FDA 510(k) clearance?

AUTION MAX AX-4060 Urinalysis System received FDA 510(k) clearance on 2023-04-13, under 510(k) number K193514.

Who is the listed applicant for AUTION MAX AX-4060 Urinalysis System?

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

What is the FDA product code for AUTION MAX AX-4060 Urinalysis System?

The FDA product code for AUTION MAX AX-4060 Urinalysis System is JIL.

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Outros registros que listam Arkray, Inc. como candidato(a)

K232416SISTEMA DE ANÁLISE DE PARTÍCULAS DE URINA AUTION EYE AI-4510 K221175Multi-Lancet Device 2, ReliOn Premier Lancing Device K200788Assure Titanium Blood Glucose Monitoring System K160062SISTEMA DE ANÁLISE DE URINA AUTION ELEVEN Semi-Automatizado

Dispositivos Relacionados (Código: JIL)

K183432cobas u 601 urinalysis test systemRoche Diagnostics K173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd.K180356inui In-Home Urine Analysis Test SystemScanadu, Inc.K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd.K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc.

Fonte oficial

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