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510(k) K231221

MDx-Chex for BC-GP by Streck — Product Code PMN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2023
Date Received
April 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Device Class
Class II
Regulation Number
866.3920
Review Panel
MI
Submission Type

Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.

Other clearances by Streck

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  • K231223 — MDx-Chex for BC-GN (July 27, 2023)
  • K212576 — MDx-Chex for BCID2 (January 19, 2022)
  • DEN200001 — Cell-Free DNA BCT (August 7, 2020)
  • K170091 — UA-Cellular Complete (February 9, 2017)
  • K160586 — XN-L CHECK (December 22, 2016)
  • K160585 — XN CAL (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160590 — XN CHECK (December 22, 2016)
  • K141964 — XN CHECK (December 5, 2014)

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