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FDA 510(k)

ARCHITECT B.R.A.H.M.S PCT, Calibradores ARCHITECT B.R.A.H.M.S PCT, Controles ARCHITECT B.R.A.H.M.S PCT

N.º K: K170652 · 2017-06-01

SolicitanteFisher Diagnostics
Fecha de decisión2017-06-01
Código de productoPRI
Comité asesorMI
DecisiónSubstantially Equivalent

Resumen del dispositivo

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Diagnostics. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K170652. The device is classified under product code PRI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls?

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Fisher Diagnostics. The 510(k) number is K170652.

When did ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls receive FDA 510(k) clearance?

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170652.

Who is the listed applicant for ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls?

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

What is the FDA product code for ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls?

The FDA product code for ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls is PRI.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: PRI)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K220262Dimension EXL LOCI BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc.K192815Elecsys BRAHMS PCTRoche DiagnosticsK173927Elecsys BRAHMS PCTRoche DiagnosticsK173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN VerifiersDiaSorin, Inc.K172713Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators setFujirebio Diagnostics,Inc.K171338B R A H M S PCT sensitive KRYPTORBrahms GmbH

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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