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FDA 510(k)

Atellica IM BRAHMS Procalcitonin (PCT)

K-Number: K181002 · 2018-07-16

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2018-07-16
Product CodePMT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Atellica IM BRAHMS Procalcitonin (PCT) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-07-16 under approval number K181002. The device is classified under product code PMT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atellica IM BRAHMS Procalcitonin (PCT)?

Atellica IM BRAHMS Procalcitonin (PCT) is a medical device that received FDA 510(k) clearance on 2018-07-16. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K181002.

When was Atellica IM BRAHMS Procalcitonin (PCT) approved by the FDA?

Atellica IM BRAHMS Procalcitonin (PCT) received FDA 510(k) clearance on 2018-07-16, under approval number K181002.

What company makes Atellica IM BRAHMS Procalcitonin (PCT)?

Atellica IM BRAHMS Procalcitonin (PCT) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Atellica IM BRAHMS Procalcitonin (PCT)?

The FDA product code for Atellica IM BRAHMS Procalcitonin (PCT) is PMT.

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Related Devices (Code: PMT)

K160911VIDAS B.R.A.H.M.S. PCT (PCT)bioMerieux, Inc. K160729Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5Roche Diagnostics DEN150009B.R.A.H.M.S PCT sensitive KRYPTORBrahms GmbH K200236VITROS BRAHMS PCT Reagent Pack and CalibratorsOrtho Clinical Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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