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510(k) DEN200001

Cell-Free DNA BCT by Streck, Inc. — Product Code QMA

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 7, 2020
Date Received
January 10, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blood Collection Device For Cell-Free Nucleic Acid
Device Class
Class II
Regulation Number
862.1676
Review Panel
CH
Submission Type

A blood collection device for cell-free nucleic acids is a device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing.

Other clearances by Streck, Inc.

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  • K212576 — MDx-Chex for BCID2 (January 19, 2022)
  • K170091 — UA-Cellular Complete (February 9, 2017)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160586 — XN-L CHECK (December 22, 2016)
  • K160585 — XN CAL (December 22, 2016)
  • K160590 — XN CHECK (December 22, 2016)
  • K141964 — XN CHECK (December 5, 2014)

Other clearances for product code QMA

  • K231776 — Cell-Free DNA BCT (July 26, 2024)