510(k) K181002

Atellica IM BRAHMS Procalcitonin (PCT) by Siemens Healthcare Diagnostics, Inc. — Product Code PMT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 16, 2018
Date Received: April 16, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Device Class: Class II
Regulation Number: 866.3215
Review Panel: MI
Submission Type

An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.

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510(k) K181002

Clearance Details

Device Classification

Other clearances by Siemens Healthcare Diagnostics, Inc.

Other clearances for product code PMT