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510(k) K202382

FilmArray Global Fever Panel External Control Kit by Biofire Defense, LLC — Product Code PMN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2020
Date Received
August 20, 2020
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.

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