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510(k) DEN150009

B.R.A.H.M.S PCT sensitive KRYPTOR by Brahms GmbH — Product Code PMT

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
February 20, 2016
Date Received
March 4, 2015
Clearance Type
Direct
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.

Other clearances by Brahms GmbH

  • K171338 — B R A H M S PCT sensitive KRYPTOR (May 31, 2017)

Other clearances for product code PMT

  • K200236 — VITROS BRAHMS PCT Reagent Pack and Calibrators (February 25, 2020)
  • K181002 — Atellica IM BRAHMS Procalcitonin (PCT) (July 16, 2018)
  • K160911 — VIDAS B.R.A.H.M.S. PCT (PCT) (June 28, 2016)
  • K160729 — Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 (June 13, 2016)