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510(k) K200236

VITROS BRAHMS PCT Reagent Pack and Calibrators by Ortho Clinical Diagnostics — Product Code PMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2020
Date Received
January 30, 2020
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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Other clearances for product code PMT

  • K181002 — Atellica IM BRAHMS Procalcitonin (PCT) (July 16, 2018)
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