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510(k) K201403

NATtrol BD MAX Vaginal Panel External Controls by Zeptometrix — Product Code PMN

K201403 is an FDA 510(k) premarket notification submitted by Zeptometrix for the device "NATtrol BD MAX Vaginal Panel External Controls". The FDA issued a decision of Substantially Equivalent on February 2, 2022. The device falls under product code PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays), a Class II device regulated under 21 CFR 866.3920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2022
Date Received
May 28, 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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FDA data resources