FDA 510(k)

Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

N.º K: K220262 · 2022-08-26

SolicitanteSiemens Healthcare Diagnostics, Inc.

Fecha de decisión2022-08-26

Código de productoPRI

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dimension EXL LOCI BRAHMS Procalcitonin (PCT) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2022-08-26 under 510(k) number K220262. 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 Dimension EXL LOCI BRAHMS Procalcitonin (PCT)?

Dimension EXL LOCI BRAHMS Procalcitonin (PCT) is a medical device that received FDA 510(k) clearance on 2022-08-26. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K220262.

When did Dimension EXL LOCI BRAHMS Procalcitonin (PCT) receive FDA 510(k) clearance?

Dimension EXL LOCI BRAHMS Procalcitonin (PCT) received FDA 510(k) clearance on 2022-08-26, under 510(k) number K220262.

Who is the listed applicant for Dimension EXL LOCI BRAHMS Procalcitonin (PCT)?

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

What is the FDA product code for Dimension EXL LOCI BRAHMS Procalcitonin (PCT)?

The FDA product code for Dimension EXL LOCI BRAHMS Procalcitonin (PCT) is PRI.

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Dispositivos relacionados (Código: PRI)

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Fuente oficial

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