FDA 510(k)

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

Número K: K162297 · 2017-04-18

Data da decisão2017-04-18

Código do produtoPTF

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2017-04-18 under 510(k) number K162297. The device is classified under product code PTF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set?

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set is a medical device that received FDA 510(k) clearance on 2017-04-18. The listed applicant is Diazyme Laboratories. The 510(k) number is K162297.

When did Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set receive FDA 510(k) clearance?

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set received FDA 510(k) clearance on 2017-04-18, under 510(k) number K162297.

Who is the listed applicant for Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set?

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

What is the FDA product code for Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set?

The FDA product code for Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set is PTF.

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Dispositivos Relacionados (Código: PTF)

K242294DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level ControlsDiasys Diagnostic Systems GmbH K222996Access PCTBeckman Coulter, Inc.K192271Access PCT, Access PCT CalibratorsBeckman Coulter, Inc.

Fonte oficial

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